The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Luer Adapter.
| Device ID | K940961 |
| 510k Number | K940961 |
| Device Name: | MONOJECT LUER ADAPTER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo 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 | 1994-03-02 |
| Decision Date | 1994-09-14 |