The following data is part of a premarket notification filed by Isotis Nv with the FDA for Open Bore Syringe.
| Device ID | K041344 |
| 510k Number | K041344 |
| Device Name: | OPEN BORE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ISOTIS NV PROF. BRONKHORSTLAAN 10-D P.O. BOX 98,3723 AB Bilthoven, NL 3723mb |
| Contact | Eliane Schutte |
| Correspondent | Eliane Schutte ISOTIS NV PROF. BRONKHORSTLAAN 10-D P.O. BOX 98,3723 AB Bilthoven, NL 3723mb |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-16 |
| Summary: | summary |