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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, Drug
510(k) Number K032742
Device Name SILVER FOAM WOUND DRESSING
Applicant
Advanced Medical Solutions, Ltd.
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact JOHN GREEN
Correspondent
Advanced Medical Solutions, Ltd.
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Correspondent Contact JOHN GREEN
Classification Product Code
FRO  
Date Received09/04/2003
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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