The following data is part of a premarket notification filed by Orthopaedic Resources Corp. with the FDA for Elastic Compression Anklet.
| Device ID | K823789 |
| 510k Number | K823789 |
| Device Name: | ELASTIC COMPRESSION ANKLET |
| Classification | Stocking, Medical Support (for General Medical Purposes) |
| Applicant | ORTHOPAEDIC RESOURCES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-16 |
| Decision Date | 1983-01-07 |