The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Colles Fracture Frame.
| Device ID | K830154 |
| 510k Number | K830154 |
| Device Name: | COLLES FRACTURE FRAME |
| Classification | Component, Traction, Invasive |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-02 |