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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystotome
510(k) Number K874997
Device Name PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
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 Number886.4350
Classification Product Code
HNY  
Date Received12/02/1987
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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