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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac)
Regulation Description Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
Definition A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.
Product CodeNYS
Regulation Number 878.4015
Device Class 2


Premarket Reviews
ManufacturerDecision
QUICK-MED TECHNOLOGIES, INC.
  GRANTED 1

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