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 |