The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Cofield Shoulder System.
| Device ID | K855183 |
| 510k Number | K855183 |
| Device Name: | COFIELD SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556019542 | K855183 | 000 |
| 03596010443762 | K855183 | 000 |
| 03596010189622 | K855183 | 000 |
| 03596010305015 | K855183 | 000 |