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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 K062653
Device Name MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
Applicant
PARNELL PHARMACEUTICALS, INC.
1525 FRANCISCO BLVD., STE. 15
SAN RAFAEL,  CA  94901
Applicant Contact FRANCIS W PARNELL
Correspondent
PARNELL PHARMACEUTICALS, INC.
1525 FRANCISCO BLVD., STE. 15
SAN RAFAEL,  CA  94901
Correspondent Contact FRANCIS W PARNELL
Classification Product Code
LFD  
Date Received09/07/2006
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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