The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Vertical Entry Sharps Container (1 Qt).
| Device ID | K945809 |
| 510k Number | K945809 |
| Device Name: | MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. ROSECRANS MEMORIAL AIRPORT St. Joseph, MO 64503 |
| Contact | K M Kroehnke |
| Correspondent | K M Kroehnke SHERWOOD MEDICAL CO. ROSECRANS MEMORIAL AIRPORT St. Joseph, MO 64503 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-03-15 |