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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Scleral
510(k) Number K880952
Device Name PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
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 Number886.4155
Classification Product Code
LXP  
Date Received03/07/1988
Decision Date 05/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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