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510(k) DEN160018

reSet by Pear Therapeutics, Inc. — Product Code PWE

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 14, 2017
Date Received: May 16, 2016
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Behavioral Therapy Device For Substance Use Disorders
Device Class: Class II
Regulation Number: 882.5801
Review Panel: NE
Submission Type

The device is intended to provide cognitive behavioral therapy to treat substance use disorder.