The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Causse Modified Teflon Piston, Otology.
| Device ID | K760437 |
| 510k Number | K760437 |
| Device Name: | CAUSSE MODIFIED TEFLON PISTON, OTOLOGY |
| 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 | 1976-08-16 |
| Decision Date | 1976-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925022980 | K760437 | 000 |
| 00821925017290 | K760437 | 000 |