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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Orbital, Extra-Ocular
510(k) Number K945172
Device Name VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact DAVID A CLAPP
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact DAVID A CLAPP
Regulation Number886.3340
Classification Product Code
HQX  
Date Received10/21/1994
Decision Date 01/17/1995
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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