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K Number
K964468
Device Name
IAMIN WET DRESSING (COPPER-SALINE)
Manufacturer
PROCYTE CORP.
Date Cleared
1997-02-03

(89 days)

Product Code
MGQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

Device Description

lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.

AI/ML Overview

The provided text describes a 510(k) summary for the Lamin® Wet Dressing (Copper-Saline) and does not contain information about a study with acceptance criteria, device performance, sample sizes, expert involvement, or adjudication methods in the context of an AI/algorithm-based device. The document is for a medical dressing, not a software or AI device. Therefore, I cannot generate the requested information based on the input provided.

N/A