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510(k) K163029

Hydris™ Oral Rinse by Biopharm Consult, LLC — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2017
Date Received
October 31, 2016
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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