SILVERLEAF CONTACT WOUND DRESSING

• K Number: K013936
• Device Name: SILVERLEAF CONTACT WOUND DRESSING
• Manufacturer: SILVERLEAF TECHNOLOGIES INC
• Date Cleared: 2003-03-18 ( 475 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

SilverLeaf Contact Wound Dressings are non-adherent antibacterial barrier dressings intended for local management of surgical wounds (donor and graft sites, incisions) and dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Device Description

SilverLeaf Contact Wound Dressing

AI/ML Overview

I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter for the SilverLeaf Contact Wound Dressing and the Indications for Use form. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as described in your request. This type of information would typically be found in the 510(k) summary or a detailed study report, neither of which is present in the provided text.

Regulation Number and Section

N/A