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510(k) K122663

ORAMOIST by Quantum, Inc. — Product Code LFD

K122663 is an FDA 510(k) premarket notification submitted by Quantum, Inc. for the device "ORAMOIST". The FDA issued a decision of Substantially Equivalent on May 30, 2013. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2013
Date Received
August 31, 2012
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