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FDA 510(k) Application Details - K041563
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K041563
Device Name
Saliva, Artificial
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
1500 LITTLETON RD.
PARSIPPANY, NJ 07054 US
Other 510(k) Applications for this Company
Contact
ANTHONY G AMITRANO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/2004
Decision Date
08/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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