The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Richards Intra-articular Shaver Blades.
| Device ID | K830153 |
| 510k Number | K830153 |
| Device Name: | RICHARDS INTRA-ARTICULAR SHAVER BLADES |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | RICHARD'S MEDICAL EQUIP., 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 | 1983-01-18 |
| Decision Date | 1983-02-28 |