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510(k) Data Aggregation
K Number
K113199Device Name
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
Manufacturer
KEVO MEDICAL SUPPLIES
Date Cleared
2012-07-30
(273 days)
Product Code
OMP, DEV
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
KEVO MEDICAL SUPPLIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kevo NPWT- αHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
Kevo NPWT - αHemo30 Foam Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers .
- Diabetic/Neuropathic Ulcers .
- Venous Insufficiency Ulcers .
- Traumatic Wounds .
- Post-Operative and Dehisced Surgical Wounds .
- Skin Flaps and Grafts .
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Device Description
The Kevo NPWT- α.Hemo30 Foam Dressing Kit is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
The Kevo NPWT- αHemo30 Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large:
Small: 100mm x 80mm x 30mm Medium: 125mm x 190mm x 30mm Large: 150mm x 250mm x 30mm
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