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510(k) K232063

SaliPen by Saliwell , Ltd. — Product Code QTT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 2023
Date Received: July 11, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Over The Counter Electrical Salivary Stimulatory System
Device Class: Class II
Regulation Number: 872.5560
Review Panel: DE
Submission Type

Over the Counter Device intended to electrically stimulate a relative increase in saliva production