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K Number
K990584
Device Name
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
Manufacturer
BROADLINE MEDICAL INDUSTRIES
Date Cleared
1999-04-23

(59 days)

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

The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.

Device Description

GAUZE SPONGES

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding Broadline Gauze Sponges. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a scientific study report.

N/A