510(k) K163476

Lubricity by You First Services, Incorporated — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2017
Date Received
December 12, 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