GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA

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 Gm Reusable And Disposable Trocar And Gm Reusable And Disposable Ultra-light Cannula.

Pre-market Notification Details

Device IDK942703
510k NumberK942703
Device Name:GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA
ClassificationLaparoscope, General & Plastic Surgery
Applicant GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne,  CA  91750
ContactDavid C Steffin
CorrespondentDavid C Steffin
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 Received1994-06-08
Decision Date1994-08-19

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