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510(k) K173808

Voutia™ by Jeffrey Ward Cash, Dds — Product Code LFD

K173808 is an FDA 510(k) premarket notification submitted by Jeffrey Ward Cash, Dds for the device "Voutia™". The FDA issued a decision of Substantially Equivalent on July 27, 2018. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2018
Date Received
December 15, 2017
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