The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for The Minimed Model 404-sp And 504-s.
Device ID | K922670 |
510k Number | K922670 |
Device Name: | THE MINIMED MODEL 404-SP AND 504-S |
Classification | Pump, Infusion |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Ray Mccartney |
Correspondent | Ray Mccartney 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 | 1992-04-13 |
Decision Date | 1993-09-16 |