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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Behavioral Therapy Device For Substance Use Disorders
510(k) Number K173681
Device Name reSET-O
Applicant
Pear Therapeutics, Inc.
745 Atlantic Ave.
Boston,  MA  02111
Applicant Contact Yuri Maricich
Correspondent
Pear Therapeutics, Inc.
745 Atlantic Ave.
Boston,  MA  02111
Correspondent Contact Nandini Murthy
Regulation Number882.5801
Classification Product Code
PWE  
Date Received12/01/2017
Decision Date 12/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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