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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 Insomnia
510(k) Number K191716
Device Name Somryst
Applicant
Pear Therapeutics, Inc.
201 Mission St. #1450
San Francisco,  CA  94105
Applicant Contact David Amor
Correspondent
Pear Therapeutics, Inc.
201 Mission St. #1450
San Francisco,  CA  94105
Correspondent Contact Yuri Maricich
Regulation Number882.5801
Classification Product Code
QVO  
Date Received06/26/2019
Decision Date 03/23/2020
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
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