MICROMEDICS EAR, NOSE AND THROAT BURS— 510(k) K895738

Name: FDA 510(k) clearance K895738
Creator: U.S. Food and Drug Administration
Published: 1989-12-19

Substantially Equivalent

Micromedics, Inc.

FDA 510(k) clearance K895738 for MICROMEDICS EAR, NOSE AND THROAT BURS, Substantially Equivalent on 1989-12-19. Applicant: Micromedics, Inc.. Device class: 1.

Clearance details

Applicant: Micromedics, Inc.
Product code: Code EQJ
Device class: Class 1
Regulation: 21 CFR 874.4140
Advisory panel: Ear, Nose, Throat
Date received: 1989-09-26
Decision date: 1989-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EQJ

product code EQJ

Malfunction: 1,552
Total: 1,552

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.