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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 K894147
Device Name VISULIN TRANSPARENT ADHESIVE DRESSING
Applicant
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Applicant Contact RICHARD DAVIS
Correspondent
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Correspondent Contact RICHARD DAVIS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/14/1989
Decision Date 08/09/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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