The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Surecut Bmb Bone Marrow Biopsy/aspiration Needle.
| Device ID | K890926 |
| 510k Number | K890926 |
| Device Name: | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Jane Aoyagi |
| Correspondent | Jane Aoyagi MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-24 |
| Decision Date | 1989-06-20 |