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FDA 510(k) Application Details - K123731
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K123731
Device Name
Saliva, Artificial
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY, NJ 07054 US
Other 510(k) Applications for this Company
Contact
PAUL KRUMM
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
12/05/2012
Decision Date
01/04/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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