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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, Battery-Powered
510(k) Number K896622
Device Name VISITEC VITRECTOMY UNIT
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact LIAQUAT ALLARAKHIA
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact LIAQUAT ALLARAKHIA
Regulation Number886.4150
Classification Product Code
HKP  
Date Received11/21/1989
Decision Date 04/04/1990
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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