FERRIS POLYOSTOMY STERILE WOUND DRESSING

• K Number: K991729
• Device Name: FERRIS POLYOSTOMY STERILE WOUND DRESSING
• Manufacturer: FERRIS MFG. CORP.
• Date Cleared: 1999-08-27 ( 99 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Ostomy Tube Sites
Drainage Tube Sites
Gastrointestinal Tube Sites
Feeding Tube Sites

Device Description

FERRIS POLYOSTOMY STERILE WOUND DRESSING

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "PolyOstomy Sterile Wound Dressing". This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, expert qualifications, or adjudication methods.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical and clinical study data used to establish substantial equivalence. To answer your request, one would typically need access to the actual 510(k) submission, which would include the performance data and supporting studies.

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.