The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Horizontal Entry Sharps Container.
| Device ID | K943485 |
| 510k Number | K943485 |
| Device Name: | MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Michael Kroehnke |
| Correspondent | Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| 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 | 1994-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521018362 | K943485 | 000 |
| 20884521018294 | K943485 | 000 |
| 20884521018287 | K943485 | 000 |