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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Cine, Endoscopic, With Audio
510(k) Number K883944
Device Name MEC-1 VIDEO COMBO SYSTEM
Applicant
Medical Concepts, Inc.
310 Olive St.
Santa Barbara,  CA  93101
Applicant Contact ANGELI MANCUSO
Correspondent
Medical Concepts, Inc.
310 Olive St.
Santa Barbara,  CA  93101
Correspondent Contact ANGELI MANCUSO
Regulation Number878.4160
Classification Product Code
FTS  
Date Received09/19/1988
Decision Date 09/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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