The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Modified Minimed Iii Infusion Pump.
Device ID | K895436 |
510k Number | K895436 |
Device Name: | MODIFIED MINIMED III INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Jeffrey H Greiner |
Correspondent | Jeffrey H Greiner 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 | 1989-08-08 |
Decision Date | 1990-05-24 |