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510(k) K181194

SmartMouth DryMouth Oral Rinse by Triumph Pharmaceuticals, Inc. — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2019
Date Received
May 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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