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510(k) Data Aggregation
K Number
K113312Device Name
HY-CHLO(TM)WOUND SCRUB
Manufacturer
PATRIN PHARMA
Date Cleared
2012-08-21
(286 days)
Product Code
FQH, FOH
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
PATRIN PHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: Hy-Chlo™ Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds.
Professional Use: Hy-Chlo™ Wound Solution is intended to be used under the supervision of healthcare professional in the cleansing of acute, chronic and/or open wounds such as Stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.
Device Description
Hy-Chlo™ Wound Solution is an aqueous, clear, colorless solution that cleans open wounds. The solution delivers sodium hypochlorite as a preservative with sodium bicarbonate as a pH modifier. Hy-Chlo™ Wound Solution will be supplied in heat sealed, impervious, mold extruded HDPE bottles. A permanent affixed label will be on each bottle.
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