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510(k) K190107

VeriSplint by Whip Mix Corporation — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2019
Date Received
January 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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