The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Magellan Ratio Dispenser Kit/magellan Spray Tip/magellan Cannula Tip.
Device ID | K020147 |
510k Number | K020147 |
Device Name: | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP |
Classification | Syringe, Piston |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
Contact | Lucy Tan |
Correspondent | Lucy Tan MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-16 |
Decision Date | 2002-04-03 |
Summary: | summary |