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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 K030802
Device Name CAPHOSOL
Applicant
INPHARMA A.S.
96 WEST MAIN ST.
NORTHBOROUGH,  MA  01532
Applicant Contact BRUCE MANNING
Correspondent
INPHARMA A.S.
96 WEST MAIN ST.
NORTHBOROUGH,  MA  01532
Correspondent Contact BRUCE MANNING
Classification Product Code
LFD  
Date Received03/13/2003
Decision Date 11/25/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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