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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mobile / tablet software application to control settings of surgical and endoscopic camera
Definition Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
Product CodeQGY
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1

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