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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K875005
Device Name PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
744 GODDARD
CHESTERFIELD,  MO  63017
Applicant Contact TODD J HESSEL
Correspondent
ADVANCED SURGICAL PRODUCTS, INC.
744 GODDARD
CHESTERFIELD,  MO  63017
Correspondent Contact TODD J HESSEL
Regulation Number878.4580
Classification Product Code
FST  
Date Received12/04/1987
Decision Date 03/14/1988
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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