The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Shea Locking Bail Prosthesis.
| Device ID | K802873 |
| 510k Number | K802873 |
| Device Name: | SHEA LOCKING BAIL PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-14 |
| Decision Date | 1980-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028647 | K802873 | 000 |
| 00821925020870 | K802873 | 000 |
| 00821925020887 | K802873 | 000 |
| 00821925020894 | K802873 | 000 |
| 00821925020900 | K802873 | 000 |
| 00821925021532 | K802873 | 000 |
| 00821925021549 | K802873 | 000 |
| 00821925021556 | K802873 | 000 |
| 00821925021563 | K802873 | 000 |
| 00821925020863 | K802873 | 000 |
| 00821925020856 | K802873 | 000 |
| 00821925015791 | K802873 | 000 |
| 00821925015807 | K802873 | 000 |
| 00821925015814 | K802873 | 000 |
| 00821925017061 | K802873 | 000 |
| 00821925017078 | K802873 | 000 |
| 00821925017085 | K802873 | 000 |
| 00821925017092 | K802873 | 000 |
| 00821925020849 | K802873 | 000 |
| 00821925021587 | K802873 | 000 |
| 00821925021983 | K802873 | 000 |
| 00821925028562 | K802873 | 000 |
| 00821925028579 | K802873 | 000 |
| 00821925028586 | K802873 | 000 |
| 00821925028593 | K802873 | 000 |
| 00821925028609 | K802873 | 000 |
| 00821925028616 | K802873 | 000 |
| 00821925028623 | K802873 | 000 |
| 00821925028630 | K802873 | 000 |
| 00821925028555 | K802873 | 000 |
| 00821925028548 | K802873 | 000 |
| 00821925022881 | K802873 | 000 |
| 00821925024311 | K802873 | 000 |
| 00821925024458 | K802873 | 000 |
| 00821925025455 | K802873 | 000 |
| 00821925025462 | K802873 | 000 |
| 00821925025868 | K802873 | 000 |
| 00821925028524 | K802873 | 000 |
| 00821925028531 | K802873 | 000 |
| 00821925015784 | K802873 | 000 |