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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K010245
Device Name ACTIVHEAL SCAR MANAGEMENT DRESSING
Applicant
Advanced Medical Solutions, Ltd.
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact CHRIS OAKES
Correspondent
Advanced Medical Solutions, Ltd.
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Correspondent Contact CHRIS OAKES
Regulation Number878.4025
Classification Product Code
MDA  
Date Received01/25/2001
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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