The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Owen Mumford 3ml Autopen.
| Device ID | K983974 |
| 510k Number | K983974 |
| Device Name: | OWEN MUMFORD 3ML AUTOPEN |
| Classification | Syringe, Piston |
| Applicant | Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1998-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384703810013 | K983974 | 000 |
| 00384703800014 | K983974 | 000 |