K014088 is an FDA 510(k) clearance for the DUPLOREACH. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on June 7, 2002, 177 days after receiving the submission on December 12, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K014088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2001 |
| Decision Date | June 07, 2002 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |