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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Scleral
510(k) Number K945114
Device Name VISITEC SCLERAL PLUG
Applicant
Visitec Co.
7575 Commerce Court
Sarasota,  FL  34243 -3218
Applicant Contact DAVID A CLAPP
Correspondent
Visitec Co.
7575 Commerce Court
Sarasota,  FL  34243 -3218
Correspondent Contact DAVID A CLAPP
Regulation Number886.4155
Classification Product Code
LXP  
Date Received10/18/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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