The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Bone Marrow Biopsy Tray.
| Device ID | K912074 |
| 510k Number | K912074 |
| Device Name: | BONE MARROW BIOPSY TRAY |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1991-08-28 |