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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 K110458
Device Name SILVER ANTIMICROBIAL WOUND GEL
Applicant
Advanced Medical Solutions Limited
Premier Park, 33 Rd. One,
Winsford Industrial Estate
Winsford Cheshire,  GB CW7 3PD
Applicant Contact CLAIRE RYAN
Correspondent
Advanced Medical Solutions Limited
Premier Park, 33 Rd. One,
Winsford Industrial Estate
Winsford Cheshire,  GB CW7 3PD
Correspondent Contact CLAIRE RYAN
Classification Product Code
FRO  
Date Received02/17/2011
Decision Date 03/14/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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