VISI-DRAPE OPHTHALMIC DRAPES

Keratome, Battery-powered

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visi-drape Ophthalmic Drapes.

Pre-market Notification Details

Device IDK902857
510k NumberK902857
Device Name:VISI-DRAPE OPHTHALMIC DRAPES
ClassificationKeratome, Battery-powered
Applicant VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
ContactLiaquat Allarakhia
CorrespondentLiaquat Allarakhia
VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
Product CodeHMY  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-29
Decision Date1990-07-31

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