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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K902010
Device Name VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact LIAQUAT ALLARAKHIA
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact LIAQUAT ALLARAKHIA
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/03/1990
Decision Date 06/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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