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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 K091013
Device Name SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
Applicant
Advanced Medical Solutions Limited
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact CLAIRE RYAN
Correspondent
Advanced Medical Solutions Limited
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Correspondent Contact CLAIRE RYAN
Classification Product Code
FRO  
Date Received04/09/2009
Decision Date 07/30/2009
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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