The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Schuring Ossicle Cup & Columella Prosth..
| Device ID | K802431 |
| 510k Number | K802431 |
| Device Name: | SCHURING OSSICLE CUP & COLUMELLA PROSTH. |
| 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 | 1980-10-06 |
| Decision Date | 1980-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925020627 | K802431 | 000 |
| 00821925014312 | K802431 | 000 |
| 00821925014350 | K802431 | 000 |
| 00821925014961 | K802431 | 000 |
| 00821925014978 | K802431 | 000 |
| 00821925014985 | K802431 | 000 |
| 00821925014992 | K802431 | 000 |
| 00821925015005 | K802431 | 000 |
| 00821925015302 | K802431 | 000 |
| 00821925015319 | K802431 | 000 |
| 00821925015326 | K802431 | 000 |
| 00821925017733 | K802431 | 000 |
| 00821925020610 | K802431 | 000 |
| 00821925014077 | K802431 | 000 |