The following data is part of a premarket notification filed by Medicalex with the FDA for Medicalex.
| Device ID | K833377 |
| 510k Number | K833377 |
| Device Name: | MEDICALEX |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | MEDICALEX 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-29 |
| Decision Date | 1984-09-27 |