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substantial equivalence
Results: 211

#	Item
111	510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following informiation provides sufficient detail to understand the basis for a determination of substantial equivalence. 1. Submitter Name Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-11-14 08:33:10 Biology Blood tests Accu-chek Insulin pump Glucose meter Diabetes management Blood sugar Blood glucose monitoring Diabetes mellitus Medicine Endocrine system Diabetes
112	Section 5JU[removed]Traditional 5 10(k) Summary This summary of the Traditional 510(k) substantial equivalence information is being submitted in Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-07-25 00:34:33 Technology Food law Dental materials Medical equipment Medical device Medical technology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Premarket approval Medicine Food and Drug Administration Health
113	510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-05-06 11:18:57 Health Medical equipment Medical technology Pharmacology Hepatology Medical device Title 21 of the Code of Federal Regulations Center for Devices and Radiological Health Bilirubin Medicine Technology Food and Drug Administration
114	MAY[removed]SION)i Summary This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR[removed]Assigned 510(k) number: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-06-06 11:54:30 Laboratory techniques Bacillaceae Molecular biology Polymerase chain reaction Anthrax Bacillus anthracis Real-time polymerase chain reaction Biological warfare Idaho Technology Biology Bacteria Chemistry
115	FES[removed]k) Summary Summary of 510 (k) safety and -ttttvefess iformation upon which the substantial equivalence determination is based: Prepared: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-03-26 00:31:57 Hallux rigidus Medical device Premarket approval Metatarsophalangeal articulations Bone cement Bunion Arthroplasty Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Medicine Food and Drug Administration Orthopedic surgery
116	fCV3[removed]Section 5 Traditional 510(k) Summary This summary of the Traditional S1O(k) substantial equivalence information isbeing submitted in accordance with the requirements of 21 CFR[removed]. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-10-09 09:32:42 Technology Food law Pharmaceuticals policy Restorative dentistry Medical device Medical equipment Federal Food Drug and Cosmetic Act Premarket approval Crown Medicine Food and Drug Administration Health
117	REVERSE MEDICAL TM ________K123803 510(k) SummaryJU Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical Corporation isproviding the summary of Substantial Equivalence for the Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-08-06 11:27:52 Medical device Medical equipment Medical technology Premarket approval Federal Food Drug and Cosmetic Act Biocompatibility Center for Devices and Radiological Health Sterilization Embolization Medicine Food and Drug Administration Surgery
118	Genetically Engineered Salmon Add to Reading List Source URL: ipmall.info Language: English - Date: 2014-05-23 15:01:51 Genetic engineering Emerging technologies Molecular biology Biotechnology Environmental issues Genetically modified food Genetically modified organism Federal Food Drug and Cosmetic Act Substantial equivalence Biology Food and drink Health
119	OCT[removed]E. GentleMAX Family of Laser Systems 510k Summary General Information: This 510(k) is to provide notification of substantial equivalence for the Candela GentleMAX Family of Laser Systems using 755 nm Alexandri Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-11-28 00:38:45 Medicine Acronyms Laser Photonics Candela Corp Nd:YAG laser Solid-state laser Yttrium aluminium garnet Optics Optical materials Laser medicine
120	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION EXECUTIVE SUMMARY A. 510(k) Number: k122397 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-10-09 13:29:38 Glycoproteins Immune system Immunologic tests Immunology Rubella Immunoglobulin M Immunoassay Rheumatoid factor Antibody Biology Medicine Pediatrics