VISITEC MICRO-SPONGE SPEARS

Sponge, Ophthalmic

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Micro-sponge Spears.

Pre-market Notification Details

Device IDK896705
510k NumberK896705
Device Name:VISITEC MICRO-SPONGE SPEARS
ClassificationSponge, Ophthalmic
Applicant VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
ContactLiaquat Allarakhia
CorrespondentLiaquat Allarakhia
VISITEC CO. 7575 COMMERCE COURT Sarasota,  FL  34243 -3218
Product CodeHOZ  
CFR Regulation Number886.4790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-28
Decision Date1990-01-11

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