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CER-10
Results: 33

#	Item
21	DEC[removed]K123137: 510(K) SUMMARY This 5 10(k) Summary is provided in accordance with 21 CER[removed]Date of preparation: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-01-09 11:27:39 Radiobiology Radioactivity Radiation therapy Isocenter Radiation treatment planning Medical device Prostate cancer Ionizing radiation Image-guided radiation therapy Medicine Radiation oncology Medical physics
22	JUL[removed]k) Summary This summary of 5 10(K) - safety and effectiveness information is being submitted in accordance with requirements of21 CER Part[removed]. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-08-29 00:30:56 Health Medical device Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Quality management system Regulatory affairs Investigational Device Exemption Medicine Food and Drug Administration Technology
23	SECTION[removed]k) SUMMARY -MAR -6 The 5 10(k) Summary is submitted in accordance with 21 CER[removed]and the requirements of the Safe Medical Device Act (SMDA) of 1990. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-04-23 00:34:07 Balloon catheter Percutaneous coronary intervention Angioplasty Angiography Percutaneous Coronary catheterization Medicine Catheters Interventional radiology
24	MAR0[removed]k) SUMMARY A summary of 5 10(k) safety and effectiveness information in accordance with the requirements of 21 CER[removed]a)(1) Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-04-10 10:15:47 Food and Drug Administration Neurotrauma External ventricular drain Medical signs Intracranial pressure monitoring Catheter Integra LifeSciences Medical device Federal Food Drug and Cosmetic Act Medicine Neurosurgery Medical equipment
25	MAR REMARKET NOTIFICATION 5 10(k) SUMMARY (As Required By 21 CER[removed]This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-04-23 00:33:47 Health Medical equipment Blood pressure Food law Code of Federal Regulations Sphygmomanometer Medical device Federal Food Drug and Cosmetic Act Premarket approval Medicine Technology Food and Drug Administration
26	510(k) Summary of Safety and Effectiveness APR This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CER[removed], 21 CFR[removed], Format for T Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-05-30 00:43:06 Food law Pharmaceuticals policy Medical device Medical technology Electrosurgery Federal Food Drug and Cosmetic Act Premarket approval Title 21 of the Code of Federal Regulations Center for Devices and Radiological Health Medicine Food and Drug Administration Medical equipment
27	5 10(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMVDA 1990 and 21 CER[removed]k) Number k131126 2. Applicant: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-09-13 12:40:27 Arterial blood gas Respiratory physiology Respiratory therapy
28	Inspire the Next SECTION[removed]k) SUMMARY This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CER[removed]The assigned 510(k) Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-09-13 12:40:16 Biochemistry Clinical pathology Hepatology Liver function tests Lactate dehydrogenase LD Amylase Alanine transaminase Medicine Enzymes Chemical pathology
29	Local Publi Chapter O c Rela ffi tions cer , Sprin g ‘10 Add to Reading List Source URL: www.nea.org Language: English - Date: 2014-09-01 01:52:03 National Education Association Education in the United States Connecticut Connecticut Education Association Southern Connecticut State University
30	Paul Hunt Submission on Regulatory Treatment of BGÉ ICs CER: Regulatory Treatment of BGÉ Interconnectors (Part II) Submission by Paul Hunt: 10 August 2011 Add to Reading List Source URL: www.cer.ie Language: English - Date: 2013-11-25 11:08:14 Regulatory capture Insurance Economics Politics Administrative law Lobbying Public choice theory