OPHTHALMIC FLUID DISTRIBUTION SETS

Tubing, Fluid Delivery

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Ophthalmic Fluid Distribution Sets.

Pre-market Notification Details

Device IDK923972
510k NumberK923972
Device Name:OPHTHALMIC FLUID DISTRIBUTION SETS
ClassificationTubing, Fluid Delivery
Applicant VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
ContactDavid A Clapp
CorrespondentDavid A Clapp
VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
Product CodeFPK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-07
Decision Date1992-11-04

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