Search Results
Found 1 results
510(k) Data Aggregation
K Number
K142775Device Name
Neuwater TM (HydrocynTM aqua)
Manufacturer
Date Cleared
2015-02-13
(140 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Vigilenz Medical Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prescription Use: Neuwater (Hydrocyn aqua) is intended for moistening acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritation of the skin.
Over-the-Counter: Neuwater (Hydrocyn aqua) is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1