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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device negative pressure wound therapy, non-powered suction pump, chemical
Regulation Description Non-Powered suction apparatus device intended for negative pressure wound therapy.
Definition For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product CodeQPX
Regulation Number 878.4683
Device Class 2


Premarket Reviews
ManufacturerDecision
AATRU MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

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