510(k) K945660 ยท KZH Introducer, Syringe Needle
AUTOJECT 2
| Applicant | Owen Mumford USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 11, 1995 |
| Received | Nov 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Owen Mumford USA, Inc. Autoject EI, REF AJ1310 Open, Classified |
KZH | None listed |
| Jul 17, 2019 | Owen Mumford USA, Inc. Petfine Auto Injector, REF 3310VET Open, Classified |
KZH | None listed |
| Apr 2, 2015 | Owen Mumford USA, Inc. 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. Terminated |
KZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.