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K Number
K971088
Device Name
OPPORTUNITY INCISION AND DRAINAGE TRAY
Manufacturer
OPPORTUNITY, INC.
Date Cleared
1997-09-16

(176 days)

Product Code
EFQ,K97
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Opportunity Inc.'s Incision and Drainage Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing incision and drainage procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA, not a study report. It states that the referenced devices (various medical trays and kits) are "substantially equivalent" to devices marketed before May 28, 1976. Substantial equivalence is a regulatory finding, not an assessment of device performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from this document. The document confirms that Opportunity Inc. can market its devices based on their substantial equivalence to existing products, but it does not contain data on device performance or a study demonstrating such performance.

N/A