The following data is part of a premarket notification filed by Corinthian Medical Ltd. with the FDA for Serenocem, Model Bc 010.
| Device ID | K003567 |
| 510k Number | K003567 |
| Device Name: | SERENOCEM, MODEL BC 010 |
| Classification | Cement, Ear, Nose And Throat |
| Applicant | CORINTHIAN MEDICAL LTD. AMSTEL 320-1 Amerstdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser CORINTHIAN MEDICAL LTD. AMSTEL 320-1 Amerstdam, NL 1017 Ap |
| Product Code | NEA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-02-12 |