The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Modified Intended Use Of Monoject Bone Marrow Need.
| Device ID | K883014 |
| 510k Number | K883014 |
| Device Name: | MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Cynthia Pestka |
| Correspondent | Cynthia Pestka 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 | 1988-07-19 |
| Decision Date | 1988-07-28 |