The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Imbibe Bone Marrow Aspiration Syringe.
| Device ID | K023074 |
| 510k Number | K023074 |
| Device Name: | IMBIBE BONE MARROW ASPIRATION SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Andreina Ide |
| Correspondent | Andreina Ide ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2003-03-11 |
| Summary: | summary |