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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K941662
Device Name GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
Applicant
GM ENGINEERING, INC.
2549 SIERRA WAY, SUITE B
LA VERNE,  CA  91750
Applicant Contact DAVID C STEFFIN
Correspondent
GM ENGINEERING, INC.
2549 SIERRA WAY, SUITE B
LA VERNE,  CA  91750
Correspondent Contact DAVID C STEFFIN
Regulation Number874.4350
Classification Product Code
EQH  
Subsequent Product Code
EOQ  
Date Received04/05/1994
Decision Date 07/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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