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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saliva, artificial
510(k) Number K024148
Device Name SALINUM, ORCLAIR
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
LFD  
Date Received12/16/2002
Decision Date 09/15/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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