MEDLINE IODOFORM PACKING STRIPS

• K Number: K052720
• Device Name: MEDLINE IODOFORM PACKING STRIPS
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Date Cleared: 2005-10-20 ( 21 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Medline Iodoform Packing strips are intended for use for general wound packing.

Device Description

Not Found

AI/ML Overview

The provided text is a No Objection Letter from the FDA for a medical device called "Medline Iodoform Packing Strips." It explicitly states that the device is "substantially equivalent" to legally marketed devices and can proceed to the market.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter is a regulatory document confirming market clearance, not a clinical study report. Therefore, I cannot extract the requested information based on the input provided.

Regulation Number and Section

N/A