The following data is part of a premarket notification filed by Hager Worldwide, Inc. with the FDA for Miramatic Safe Syringe System.
| Device ID | K043322 |
| 510k Number | K043322 |
| Device Name: | MIRAMATIC SAFE SYRINGE SYSTEM |
| Classification | Syringe, Cartridge |
| Applicant | HAGER WORLDWIDE, INC. 4 LINCOLN ST Andover, MA 01810 |
| Contact | James Delaney |
| Correspondent | James Delaney HAGER WORLDWIDE, INC. 4 LINCOLN ST Andover, MA 01810 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-07-21 |
| Summary: | summary |