The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Magellan Ratio Dispenser Kit.
Device ID | K041830 |
510k Number | K041830 |
Device Name: | MAGELLAN RATIO DISPENSER KIT |
Classification | Syringe, Piston |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Bruce Backlund |
Correspondent | Bruce Backlund MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-07 |
Decision Date | 2004-09-29 |
Summary: | summary |