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510(k) Data Aggregation
K Number
K080010Device Name
NOCC HYDROPHILIC WOUND DRESSING
Manufacturer
KYTOGENICS, INC
Date Cleared
2008-03-14
(71 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KYTOGENICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree burns.
Device Description
NOCC™ (N,O-Carboxymethylchitosan) Hydrophilic Wound Dressing is a hydrogel that provides a moist wound environment to support wound healing. The gel is clear which aids in visualization of the wound.
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