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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 K991938
Device Name CAPHOSOL ARTIFICIAL SALIVA
Applicant
Inpharma A.S.
P.O. Box 809, 27 S. St.
Northborough,  MA  01532
Applicant Contact BRUCE R MANNING
Correspondent
Inpharma A.S.
P.O. Box 809, 27 S. St.
Northborough,  MA  01532
Correspondent Contact BRUCE R MANNING
Classification Product Code
LFD  
Date Received06/09/1999
Decision Date 08/10/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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