GENERAL PROCEDURE KIT

Syringe, Piston

PHYSICIAN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Physician Industries, Inc. with the FDA for General Procedure Kit.

Pre-market Notification Details

Device IDK960248
510k NumberK960248
Device Name:GENERAL PROCEDURE KIT
ClassificationSyringe, Piston
Applicant PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake,  UT  84054 -0793
ContactBrian Baker
CorrespondentBrian Baker
PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake,  UT  84054 -0793
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-04-12

NIH GUDID Devices

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