ARTICULATING RETRACTOR TISSUE RETRACTORS

Laparoscope, General & Plastic Surgery

GM ENGINEERING, INC.

The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Articulating Retractor Tissue Retractors.

Pre-market Notification Details

Device IDK953348
510k NumberK953348
Device Name:ARTICULATING RETRACTOR TISSUE RETRACTORS
ClassificationLaparoscope, General & Plastic Surgery
Applicant GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne,  CA  91750
ContactJared K Larsen
CorrespondentJared K Larsen
GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne,  CA  91750
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-17
Decision Date1995-09-12

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