FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER

• K Number: K990906
• Device Name: FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
• Manufacturer: FERRIS MFG. CORP.
• Date Cleared: 1999-04-29 ( 42 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K970706

Intended Use

Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers

Device Description

FERRIS ... LOLLEWIC CARLY WOUND FILLER

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a wound filler product named "PolyMem PolyWic Sterile Cavity Wound Filler". This document does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the regulatory clearance of the device based on its substantial equivalence to a legally marketed predicate device, its intended uses, and limitations on its labeling claims.

Therefore, I cannot provide the requested information as it is not present in the given text.

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.