The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Bone Marrow Biopsy Trays.
| Device ID | K945109 |
| 510k Number | K945109 |
| Device Name: | MONOJECT BONE MARROW BIOPSY TRAYS |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1994-11-14 |