The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed 407c Infusion Pump, Model 407c.
Device ID | K991013 |
510k Number | K991013 |
Device Name: | MINIMED 407C INFUSION PUMP, MODEL 407C |
Classification | Pump, Infusion |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Don Selvey |
Correspondent | Don Selvey MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-26 |
Decision Date | 1999-06-23 |
Summary: | summary |