The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Orthopaedic Cable System.
| Device ID | K842977 |
| 510k Number | K842977 |
| Device Name: | ORTHOPAEDIC CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robet F Games |
| Correspondent | Robet F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-10-26 |