VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}

Plug, Punctum

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Collar Button Catheter {griffiths}.

Pre-market Notification Details

Device IDK953394
510k NumberK953394
Device Name:VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
ClassificationPlug, Punctum
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 CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-17
Decision Date1995-10-12

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