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FDA 510(k) Applications Submitted by Otsuka America Pharmaceutical, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K251088
04/09/2025
Otsuka Digital Feedback Device
Otsuka America Pharmaceutical, Inc.
K231209
04/27/2023
Rejoyn
Otsuka America Pharmaceutical, Inc.
K223463
11/16/2022
Otsuka Digital Feedback Device-RW
Otsuka America Pharmaceutical, Inc.
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