The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject High Volume/chemotherapy Sharps Container.
| Device ID | K943578 |
| 510k Number | K943578 |
| Device Name: | MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | K. Michael Kroehnke |
| Correspondent | K. Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-08-23 |