The following data is part of a premarket notification filed by Asahi Optical Co. C/o Rosati Associates, P.c. with the FDA for Apaceram Ossicular Prosthesis.
| Device ID | K893134 |
| 510k Number | K893134 |
| Device Name: | APACERAM OSSICULAR PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. ATTORNEY & COUNSELOR AT LAW 31815 SOUTHFIELD ROAD - #15 Birmingham, MI 48009 |
| Contact | Samuel C Ursu |
| Correspondent | Samuel C Ursu ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. ATTORNEY & COUNSELOR AT LAW 31815 SOUTHFIELD ROAD - #15 Birmingham, MI 48009 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-08-03 |