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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K042722
Device Name ALOCLAIR ORAL SPRAY
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
OLR  
Date Received10/01/2004
Decision Date 01/13/2005
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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