K003908 is an FDA 510(k) clearance for the SEROJET. This device is classified as a Injector, Fluid, Non-electrically Powered (Class II - Special Controls, product code KZE).
Submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on March 8, 2001, 79 days after receiving the submission on December 19, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5430.
| 510(k) Number | K003908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2000 |
| Decision Date | March 08, 2001 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZE — Injector, Fluid, Non-electrically Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5430 |