POINT OF USE SHARPS A GATOR

Needle, Hypodermic, Single Lumen

DEVON INDUSTRIES, INC.

The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Point Of Use Sharps A Gator.

Pre-market Notification Details

Device IDK943892
510k NumberK943892
Device Name:POINT OF USE SHARPS A GATOR
ClassificationNeedle, Hypodermic, Single Lumen
Applicant DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth,  CA  91311
ContactGeorge Austria
CorrespondentGeorge Austria
DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth,  CA  91311
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-09
Decision Date1994-12-02

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