VISITEC IRRIGATION CONTROL SYSTEM

Device, Irrigation, Ocular Surgery

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Irrigation Control System.

Pre-market Notification Details

Device IDK853243
510k NumberK853243
Device Name:VISITEC IRRIGATION CONTROL SYSTEM
ClassificationDevice, Irrigation, Ocular Surgery
Applicant VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
ContactThomas B Givens
CorrespondentThomas B Givens
VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
Product CodeKYG  
CFR Regulation Number886.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-01
Decision Date1985-09-11

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