The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Paradigm Reservoir, Model Mmt-332.
Device ID | K032005 |
510k Number | K032005 |
Device Name: | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 |
Classification | Pump, Infusion |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Contact | Mirielle Mengotto |
Correspondent | Mirielle Mengotto MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-30 |
Decision Date | 2003-08-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40643169786545 | K032005 | 000 |
40643169786552 | K032005 | 000 |
20763000273358 | K032005 | 000 |