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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computerized behavioral therapy device for depressive disorders.
Definition The device is intended to provide computerized behavioral therapy to treat depressive disorders.
Product CodeSAP
Regulation Number 882.5801
Device Class 2


Premarket Reviews
ManufacturerDecision
OTSUKA AMERICA PHARMACEUTICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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