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K Number
K971075
Device Name
PRIMED PRIME-PLUS COTTON GAUZE SPONGES
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
1997-06-22

(90 days)

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

Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.

Device Description

Cotton Gauze Sponges

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for "priMED 'Prime-Plus' Cotton Gauze Sponges" and a "Statement of Indications for Use."

This type of document primarily confirms that a medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or is as safe and effective.

The provided text does not contain any information about acceptance criteria for device performance, study details, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the full 510(k) submission, study reports, or design control documentation, which are not part of these specific pages.

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