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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K853243
Device Name VISITEC IRRIGATION CONTROL SYSTEM
Applicant
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Applicant Contact THOMAS B GIVENS
Correspondent
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Correspondent Contact THOMAS B GIVENS
Regulation Number886.4360
Classification Product Code
KYG  
Date Received08/01/1985
Decision Date 09/11/1985
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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