The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Magellan Insulin And Tuberculin Safety Syringe.
| Device ID | K061492 |
| 510k Number | K061492 |
| Device Name: | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Michelle Kelley |
| Correspondent | Michelle Kelley TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-31 |
| Decision Date | 2006-08-03 |
| Summary: | summary |