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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 K843487
Device Name VISITEC OPHTHALMIC FLUID DISTRIB- SET
Applicant
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Applicant Contact EUGENE H BECKSTEIN
Correspondent
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Correspondent Contact EUGENE H BECKSTEIN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/06/1984
Decision Date 03/13/1985
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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