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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Chemical Solution
510(k) Number K023046
Device Name SST SALIVA SUPPORTING TABLETS
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
Regulation Number864.1850
Classification Product Code
LED  
Date Received09/12/2002
Decision Date 12/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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