The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Prosthesis, Richards Mod Ii Knee.
| Device ID | K760245 |
| 510k Number | K760245 |
| Device Name: | PROSTHESIS, RICHARDS MOD II KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-19 |
| Decision Date | 1976-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010134622 | K760245 | 000 |
| 03596010134615 | K760245 | 000 |