AUTOJECT 2— 510(k) K945660
Substantially EquivalentOwen Mumford USA, Inc.
FDA 510(k) clearance K945660 for AUTOJECT 2, Substantially Equivalent on 1995-08-11. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code KZH
view allMore clearances from Owen Mumford USA, Inc.
view allAdverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K945660
K-number listed on FDA's recall record- Z-0263-2020 — Autoject EI, REF AJ1310
- Z-0264-2020 — Petfine Auto Injector, REF 3310VET
- Z-1366-2015 — Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.