VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS

Implant, Orbital, Extra-ocular

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Silicone Retinal Implants/explants.

Pre-market Notification Details

Device IDK945172
510k NumberK945172
Device Name:VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
ClassificationImplant, Orbital, Extra-ocular
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 CodeHQX  
CFR Regulation Number886.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-21
Decision Date1995-01-17

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