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§878.4780. Powered suction pump. — Inbound Citations

21 C.F.R. § 878.4780

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 878.4780 as a whole

  • (a) A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.