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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Patient, Ophthalmic
510(k) Number K945738
Device Name VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
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 Number878.4370
Classification Product Code
HMT  
Date Received11/23/1994
Decision Date 02/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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