PREFILLED CATHETER INFLATION SYRINGE

Accessories, Catheter, G-u

AVAIL MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Avail Medical Products, Inc. with the FDA for Prefilled Catheter Inflation Syringe.

Pre-market Notification Details

Device IDK112209
510k NumberK112209
Device Name:PREFILLED CATHETER INFLATION SYRINGE
ClassificationAccessories, Catheter, G-u
Applicant AVAIL MEDICAL PRODUCTS, INC. 5950 NANCY RIDGE ROAD SUITE 500 San Diego,  CA  92121
ContactSteven A Howell
CorrespondentSteven A Howell
AVAIL MEDICAL PRODUCTS, INC. 5950 NANCY RIDGE ROAD SUITE 500 San Diego,  CA  92121
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-01
Decision Date2011-09-08
Summary:summary

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