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K Number
K982667
Device Name
MICROMEDICS NASAL SEPTAL BUTTON
Manufacturer
MICROMEDICS, INC.
Date Cleared
1998-11-24

(116 days)

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

Non-surgical closure of nasal septum perforation

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Nasal Septal Button" by Micromedics, Inc. It states that the device is substantially equivalent to a pre-amendment device and can be marketed.

Crucially, this document does NOT contain any information regarding acceptance criteria or the results of a study to prove device performance.

The letter is a regulatory clearance document, not a performance study report. It indicates that the device is cleared for non-surgical closure of nasal septum perforation based on substantial equivalence to devices marketed prior to May 28, 1976. This substantial equivalence determination means the FDA did not require a new clinical study to establish safety and effectiveness for this type of device.

Therefore, I cannot provide the requested information because it is not present in the provided text.

N/A