The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Egg-top Torp And Egg-top Porp.
| Device ID | K864443 |
| 510k Number | K864443 |
| Device Name: | EGG-TOP TORP AND EGG-TOP PORP |
| 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 | 1987-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925017429 | K864443 | 000 |
| 00821925015364 | K864443 | 000 |
| 00821925014343 | K864443 | 000 |
| 00821925014336 | K864443 | 000 |
| 00821925012257 | K864443 | 000 |
| 00821925012240 | K864443 | 000 |
| 00821925012233 | K864443 | 000 |
| 00821925012226 | K864443 | 000 |