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510(k) K163476

Lubricity by You First Services, Incorporated — Product Code LFD

K163476 is an FDA 510(k) premarket notification submitted by You First Services, Incorporated for the device "Lubricity". The FDA issued a decision of Substantially Equivalent on May 10, 2017. The device falls under product code LFD (Saliva, Artificial), a Class U device.

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

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FDA data resources