AUTOJECT MINI— 510(k) K953735

Name: FDA 510(k) clearance K953735
Creator: U.S. Food and Drug Administration
Published: 1995-11-08

Substantially Equivalent

Owen Mumford USA, Inc.

FDA 510(k) clearance K953735 for AUTOJECT MINI, Substantially Equivalent on 1995-11-08. Applicant: Owen Mumford USA, Inc.. Device class: 2.

Clearance details

Applicant: Owen Mumford USA, Inc.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1995-08-10
Decision date: 1995-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.