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 |