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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 Depressive Disorders.
510(k) Number K231209
Device Name Rejoyn
Applicant
Otsuka America Pharmaceutical, Inc.
2440 Research Boulevard
Rockville,  MD  20850
Applicant Contact Nancy Teague
Correspondent
Otsuka America Pharmaceutical, Inc.
2440 Research Boulevard
Rockville,  MD  20850
Correspondent Contact Nancy Teague
Regulation Number882.5801
Classification Product Code
SAP  
Date Received04/27/2023
Decision Date 03/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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