K041344 is an FDA 510(k) clearance for the OPEN BORE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Isotis NV (Bilthoven, NL). The FDA issued a Cleared decision on July 16, 2004, 57 days after receiving the submission on May 20, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K041344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2004 |
| Decision Date | July 16, 2004 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| 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 |