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FDA 510(k) Application Details - K171542
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K171542
Device Name
Saliva, Artificial
Applicant
Dr. Harold Katz, LLC (dba TheraBreath
5802 Willoughby Avenue
Los Angeles, CA 90038 US
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Contact
Harold Katz
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFD
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More FDA Info for this Product Code
Date Received
05/26/2017
Decision Date
03/16/2018
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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