FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K113583

Device Name

CURAD ANTIBACTERIAL BANDAGE

Manufacturer

MEDLINE INDUSTRIES, INC.

Date Cleared

2012-04-12

(129 days)

Product Code

FRO

Regulation Number

N/A

Type

Traditional

Panel

Reference & Predicate Devices

N/A

Intended Use

Antibacterial bandages are to be applied topically to the skin to help prevent infection in minor cuts, scrapes and burns.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Curad Antibacterial Bandage. It does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from this document.

Summary

Regulation Number and Section

N/A