The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed(r) Model 506 External Insulin Pump.
| Device ID | K901588 |
| 510k Number | K901588 |
| Device Name: | MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Cynthia Luchetti |
| Correspondent | Cynthia Luchetti MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-05 |
| Decision Date | 1990-07-02 |