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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name illuminator, fiberoptic, surgical field
510(k) Number K883856
Device Name FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
750 GODDARD AVE.
CHESTERFIELD,  MO  63005
Applicant Contact TODD J HESSEL
Correspondent
ADVANCED SURGICAL PRODUCTS, INC.
750 GODDARD AVE.
CHESTERFIELD,  MO  63005
Correspondent Contact TODD J HESSEL
Regulation Number878.4580
Classification Product Code
HBI  
Date Received09/13/1988
Decision Date 09/29/1988
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
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