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510(k) Data Aggregation
K Number
K100948Device Name
HYPO CLENZ WOUND WASH MODEL 100 PPM
Manufacturer
Date Cleared
2011-02-02
(302 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NEVOA LIFE SCIENCES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical cleansing (irrigation) of material from minor cuts, minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact skin.
Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended to be used by health care professionals in the management of wounds such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
Device Description
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