The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for 3.0 Ml Reservoir, Model 103/193.
| Device ID | K991936 |
| 510k Number | K991936 |
| Device Name: | 3.0 ML RESERVOIR, MODEL 103/193 |
| Classification | Pump, Infusion |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons 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 | 1999-06-09 |
| Decision Date | 2000-01-18 |
| Summary: | summary |