The following data is part of a premarket notification filed by Medicalex with the FDA for Medicalex.
| Device ID | K831728 |
| 510k Number | K831728 |
| Device Name: | MEDICALEX |
| Classification | Bandage, Elastic |
| Applicant | MEDICALEX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-31 |
| Decision Date | 1984-01-09 |