The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Paradigm 1.5ml Reservoir, Model 326.
| Device ID | K001828 |
| 510k Number | K001828 |
| Device Name: | PARADIGM 1.5ML RESERVOIR, MODEL 326 |
| Classification | Pump, Infusion |
| Applicant | MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons MINIMED, INC. 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 | 2000-06-16 |
| Decision Date | 2000-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40643169771435 | K001828 | 000 |
| 40643169771411 | K001828 | 000 |
| 20763000273334 | K001828 | 000 |