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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic storage cover
Regulation Description Endoscope and accessories.
Definition To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Product CodeOCU
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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