CONTINUOUS FLOW BIOPSY PROBE

Resectoscope, Working Element

GM ENGINEERING, INC.

The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Continuous Flow Biopsy Probe.

Pre-market Notification Details

Device IDK942626
510k NumberK942626
Device Name:CONTINUOUS FLOW BIOPSY PROBE
ClassificationResectoscope, Working Element
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 CodeFDC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-02
Decision Date1995-05-30

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