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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K012265
Device Name METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
Applicant
CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Applicant Contact WAYNE B STERNER
Correspondent
CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
FCW  
Subsequent Product Codes
FCR   FFS   GCT  
Date Received07/19/2001
Decision Date 10/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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