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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 K024298
Device Name ANTIMICROBIAL ALGINATE 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 Received12/24/2002
Decision Date 06/30/2003
Decision Substantially Equivalent (SESE)
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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