K000482 is an FDA 510(k) clearance for the MODIFICATION TO AUTOJECT MINI. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Owen Mumford, Ltd. (Marietta, US). The FDA issued a Cleared decision on March 6, 2000, 21 days after receiving the submission on February 14, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K000482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2000 |
| Decision Date | March 06, 2000 |
| Days to Decision | 21 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 |