The following data is part of a premarket notification filed by Owen Mumford, Ltd. with the FDA for Ez Syringe.
| Device ID | K011951 |
| 510k Number | K011951 |
| Device Name: | EZ SYRINGE |
| Classification | Syringe, Piston |
| Applicant | OWEN MUMFORD, LTD. 1755 A WEST OAK COMMONS COURT Marietta, GA 30062 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw OWEN MUMFORD, LTD. 1755 A WEST OAK COMMONS COURT 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 | 2001-06-21 |
| Decision Date | 2001-08-02 |
| Summary: | summary |