The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Mpl Hypo Brand Breech Load Aspir Syringe.
| Device ID | K843314 |
| 510k Number | K843314 |
| Device Name: | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE |
| Classification | Syringe, Cartridge |
| Applicant | SMITH & NEPHEW, MPL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-24 |
| Decision Date | 1984-09-27 |