The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Richards Intra-articular Shaver Motor.
| Device ID | K842475 | 
| 510k Number | K842475 | 
| Device Name: | RICHARDS INTRA-ARTICULAR SHAVER MOTOR | 
| Classification | Motor, Surgical Instrument, Ac-powered | 
| Applicant | RICHARDS MEDICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | GEY | 
| CFR Regulation Number | 878.4820 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-06-25 | 
| Decision Date | 1984-09-17 |