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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K991852
Device Name OCUSYSTEM ART ADVANTAGE, MODEL 995
Applicant
SURGICAL DESIGN CORP.
1050 CONNECTICUT AVENUE, NW
WASHINGTON,  DC  20036 -5339
Applicant Contact WAYNE H MATELSKI
Correspondent
SURGICAL DESIGN CORP.
1050 CONNECTICUT AVENUE, NW
WASHINGTON,  DC  20036 -5339
Correspondent Contact WAYNE H MATELSKI
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/01/1999
Decision Date 07/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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