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FDA 510(k) Application Details - K162167
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K162167
Device Name
Saliva, Artificial
Applicant
EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead HP2-4TZ GB
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Contact
Paul Davisson
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
08/03/2016
Decision Date
03/31/2017
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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