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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 Ave., NW
Washington,  DC  20036 -5339
Applicant Contact WAYNE H MATELSKI
Correspondent
Surgical Design Corp.
1050 Connecticut Ave., 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
Predetermined Change
Control Plan Authorized		 No
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