The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Mimimed Sil-serter Infusion Set Insertion System, Model 385.
| Device ID | K010377 |
| 510k Number | K010377 |
| Device Name: | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 |
| Classification | Introducer, Syringe Needle |
| Applicant | MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-08 |
| Decision Date | 2001-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000381080 | K010377 | 000 |