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510(k) K152201

MedActive Oral Gel and Spray by Medactive Oral Pharmaceuticals, LLC — Product Code LFD

K152201 is an FDA 510(k) premarket notification submitted by Medactive Oral Pharmaceuticals, LLC for the device "MedActive Oral Gel and Spray". The FDA issued a decision of Substantially Equivalent on December 30, 2015. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2015
Date Received
August 6, 2015
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