VISITEC 2 MICRON FLUID FILTER

Instrument, Vitreous Aspiration And Cutting, Ac-powered

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec 2 Micron Fluid Filter.

Pre-market Notification Details

Device IDK853135
510k NumberK853135
Device Name:VISITEC 2 MICRON FLUID FILTER
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
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 CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-26
Decision Date1985-08-09

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