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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Hydrophilic
510(k) Number K082208
Device Name DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
Applicant
Scivolutions, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Scivolutions, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number878.4018
Classification Product Code
NAC  
Date Received08/05/2008
Decision Date 12/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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