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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 K023155
Device Name ALOCLAIR ORAL RINSE
Applicant
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Applicant Contact DENISE SWIFT
Correspondent
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Correspondent Contact DENISE SWIFT
Classification Product Code
OLR  
Date Received09/23/2002
Decision Date 11/25/2002
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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