PRE-FILLED 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 Pre-filled Catheter Inflation Syringe.

Pre-market Notification Details

Device IDK090121
510k NumberK090121
Device Name:PRE-FILLED CATHETER INFLATION SYRINGE
ClassificationAccessories, Catheter, G-u
Applicant AVAIL MEDICAL PRODUCTS, INC. 1900 EAST CARNEGIE AVE. Santa Ana,  CA  92705
ContactPatricia A Goeree
CorrespondentPatricia A Goeree
AVAIL MEDICAL PRODUCTS, INC. 1900 EAST CARNEGIE AVE. Santa Ana,  CA  92705
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-21
Decision Date2009-04-15
Summary:summary

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