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Medical device / Federal Food / Drug / and Cosmetic Act / Laparoscopic surgery / Center for Devices and Radiological Health / Validation / Percutaneous / Catheter / Natural orifice translumenal endoscopic surgery / Breast implant / Medicine / Food and Drug Administration / Premarket approval


Federal Register / Vol. 68, No[removed]Wednesday, April 30, [removed]Notices regulation of a drug product under the act. Mr. Kokes was provided 30 days to
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Document Date: 2010-12-01 11:14:25

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File Size: 208,03 KB

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City

Rockville / Chicago / /

Company

Laser Fiber Delivery Systems / OIG Special Advisory Bulletin / Special Advisory Bulletin / Contractual Joint Ventures / /

Currency

USD / /

Event

Product Issues / Judicial Event / /

Facility

Hospital General / Hospital Infection / /

IndustryTerm

subsequent processing / Blood access device / reprocessed single-use device / clinical diagnostic laboratory services / drug product / predicate device / abbreviated new drug applications / reprocessed single-use devices / identified devices / devices / diagnostic services / biopsy device / durable medical equipment / appropriate risk-based tool / manufacturing / exempt devices / /

MedicalCondition

Hospital Infection / Infections / Creutzfeldt-Jakob Disease / CJD / infection / Nonsocomial Infections / CJD infectious agents / both infection / /

MedicalTreatment

intravascular catheter / IPPB / Oocyte aspiration / angioplasty / Percutaneous transluminal angioplasty / neurosurgery / plastic surgery / Surgery / Surgery Surgery / catheter / Breast Implant / drainage / Hemodialysis / brachytherapy / dialysis / Respiratory Therapy / /

Organization

DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt / Office of Inspector General / Food and Drug Administration / Office of Device Evaluation / Electrosurgical Endoscopic Unit / Phacofragmentation Unit / Validation Data AGENCY / Medicare / Congress / American Hospital Association / Center for Devices and Radiological Health / FSA / FDA / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH AND HUMAN SERVICES Office / /

Person

MIA BTR BZD DQO DRF / Publication / GAD HXM HSO GES GDZ / Steven K. Galson / Jeffrey Shuren / Therefore / HTD GDH HBT GDG MDM / Edwin Kokes / Joel Schaer / Vicki Robinson / /

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Position

Drill and Wire Driver / General / Deputy Director / Director / Hospital General / /

Product

performance / /

ProgrammingLanguage

C / /

ProvinceOrState

Maryland / /

Technology

html / Fiber Optic / Laser / neurosurgery / http / DSP / dialysis / /

URL

www.fda.gov/dockets/ecomments / www.fda.gov/cdrh / /

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