K970479 is an FDA 510(k) clearance for the MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on March 31, 1997, 52 days after receiving the submission on February 7, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K970479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1997 |
| Decision Date | March 31, 1997 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH — Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |