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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K024367
FOIA Releasable 510(k) K024367
Device Name SINCLAIR WOUND AND SKIN EMULSION
Applicant
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Applicant Contact MICHAEL KILLEEN
Correspondent
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Correspondent Contact MICHAEL KILLEEN
Classification Product Code
MGQ  
Date Received12/31/2002
Decision Date 07/28/2003
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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