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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 K091718
Device Name NEUTRASAL
Applicant
BARTOR PHARMACAL CO., INC.
25 RAVENNA DRIVE
POMONA,  NY  10970
Applicant Contact EDWARD D KOBUS
Correspondent
BARTOR PHARMACAL CO., INC.
25 RAVENNA DRIVE
POMONA,  NY  10970
Correspondent Contact EDWARD D KOBUS
Classification Product Code
LFD  
Date Received06/11/2009
Decision Date 09/02/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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