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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K915809
Device Name VISITEC CANALICULAR STENT
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact DAVID CLAPP
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact DAVID CLAPP
Classification Product Code
LZU  
Date Received12/24/1991
Decision Date 02/24/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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