SAFE VENT SYSTEM

Syringe, Piston

INCUTECH, INC.

The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Safe Vent System.

Pre-market Notification Details

Device IDK942394
510k NumberK942394
Device Name:SAFE VENT SYSTEM
ClassificationSyringe, Piston
Applicant INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro,  NC  27407
ContactRoger V Molina
CorrespondentRoger V Molina
INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro,  NC  27407
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-19
Decision Date1995-01-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884527004228 K942394 000

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