GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT

Source, Carrier, Fiberoptic Light

GM ENGINEERING, INC.

The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Gm Opti*cam Camer With Dental Fiber Optic Light.

Pre-market Notification Details

Device IDK941661
510k NumberK941661
Device Name:GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
ClassificationSource, Carrier, Fiberoptic Light
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 CodeEQH  
CFR Regulation Number874.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-05
Decision Date1994-08-23

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