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510(k) Data Aggregation
K Number
K111313Device Name
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
Manufacturer
ALCAVIS HDC LLC
Date Cleared
2011-12-14
(218 days)
Product Code
FQH
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
ALCAVIS HDC LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: ExSept Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor skin and nail irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.
Device Description
ExSept Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept Skin and Wound Cleanser contains a preservative permitting a 30 month shelf life.
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