The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Injectomatic.
| Device ID | K832683 |
| 510k Number | K832683 |
| Device Name: | MONOJECT INJECTOMATIC |
| Classification | Introducer, Syringe Needle |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-09 |
| Decision Date | 1983-09-12 |