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Food and Drug Administration / Food law / Medical equipment / Catheters / Federal Food / Drug / and Cosmetic Act / Pharmaceuticals policy / Premarket approval / Medical device / Center for Devices and Radiological Health / Medicine / Medical technology / Technology


AVAIL MEDICAL PRODUCTS, INC., Premarket Notification Pre-filled Catheter Inflation Syringe K1[removed]M edcal5950 FLEX F L YFM
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Document Date: 2011-10-31 00:34:02

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File Size: 139,19 KB

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Company

AVAIL MEDICAL PRODUCTS INC. / Accessories (21 CFR876.5130) Product Code KNY Legally / Products Inc. / 48 AVAIL MEDICAL PRODUCTS INC. / SUMMARY Information Avail Medical Products Inc. / /

Event

FDA Phase / /

IndustryTerm

predicate device / manufacturing practice requirements / plunger rubber / Internet address littp /

MedicalTreatment

Catheter / /

Organization

Center for Devices and Radiological Health / office of Compliance / Division~of Reproductive / Gastro-Renal and Urological Devices office / Division of lPostmarket Surveillance / office of Device Evaluation / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Silver Spring / Steven A. H-owell / P.Lerner / Foley / /

/

Position

Senior Director / /

Product

sterile water / Federal Food / K1 / /

ProvinceOrState

Maryland / /

Technology

radiation / ATM / SAN / /

SocialTag