The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Tyco Healthcar with the FDA for Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle.
| Device ID | K073122 |
| 510k Number | K073122 |
| Device Name: | MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Debora Stapleton |
| Correspondent | Debora Stapleton COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-06 |
| Decision Date | 2007-11-21 |
| Summary: | summary |