DUMEX PAK-ITS WOVEN RIBBON PACKING

• K Number: K980791
• Device Name: DUMEX PAK-ITS WOVEN RIBBON PACKING
• Manufacturer: DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
• Date Cleared: 1998-04-29 ( 58 days)
• Product Code: EFQ , EFO
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Dumex Pak-its Woven Ribbon Packing" device, outlining its substantial equivalence to a predicate device and its intended use and limitations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the given input.

Regulation Number and Section

N/A