The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Tray Size Sharps Container.
| Device ID | K943496 |
| 510k Number | K943496 |
| Device Name: | MONOJECT TRAY SIZE SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
| Contact | Michael Kroehnke |
| Correspondent | Michael Kroehnke SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-08-29 |