The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Shea Cupped Torp With Hydroxylapatite Flange.
| Device ID | K864444 |
| 510k Number | K864444 |
| Device Name: | SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE |
| Classification | Replacement, Ossicular Prosthesis, Total |
| 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 | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925017412 | K864444 | 000 |
| 00821925017405 | K864444 | 000 |
| 00821925017399 | K864444 | 000 |
| 00821925017382 | K864444 | 000 |
| 00821925015371 | K864444 | 000 |
| 00821925015357 | K864444 | 000 |
| 00821925015340 | K864444 | 000 |
| 00821925015333 | K864444 | 000 |