The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Ba400 14mm Abutment.
| Device ID | K150555 |
| 510k Number | K150555 |
| Device Name: | BA400 14mm Abutment |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial, CO 80111 |
| Contact | Tristan Manus |
| Correspondent | Tristan Manus COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial, CO 80111 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-04 |
| Decision Date | 2015-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502028202 | K150555 | 000 |
| 09321502033886 | K150555 | 000 |
| 09321502033459 | K150555 | 000 |
| 09321502033442 | K150555 | 000 |