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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 K933208
Device Name BARE-FIBER ENDOILLUMINATOR
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 Received07/01/1993
Decision Date 12/14/1993
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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