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FDA 510(k) Application Details - K201277
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K201277
Device Name
Saliva, Artificial
Applicant
The Procter & Gamble Company
1 Procter & Gamble Plaza
Cincinnati, OH 45202 US
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Contact
Michael A Kaminski
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
05/13/2020
Decision Date
09/02/2020
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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