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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K910973
Device Name DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
Applicant
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact ALAN T BECKMAN
Correspondent
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact ALAN T BECKMAN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/07/1991
Decision Date 04/26/1991
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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