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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Ophthalmic
510(k) Number K941660
Device Name GM OPTI*CAM CAMERA WITH 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 Number876.1500
Classification Product Code
KYH  
Date Received04/05/1994
Decision Date 05/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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