The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Aspirex - Bone Marrow Aspirate Kit.
| Device ID | K041991 |
| 510k Number | K041991 |
| Device Name: | ASPIREX - BONE MARROW ASPIRATE KIT |
| Classification | Syringe, Piston |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-09-16 |
| Summary: | summary |