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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, television, endoscopic, without audio
510(k) Number K926166
Device Name COAST VIDEO ENDOSCOPIC IMAGING SYSTEM
Applicant
OPTIK
1370 BLAIR DR.
ODENTON,  MD  21113
Applicant Contact JOHN M AHERN
Correspondent
OPTIK
1370 BLAIR DR.
ODENTON,  MD  21113
Correspondent Contact JOHN M AHERN
Regulation Number878.4160
Classification Product Code
FWF  
Date Received12/08/1992
Decision Date 06/01/1993
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
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