The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Bia300 Series Implant And Abutment, Bi300 Implant, Ba300 Abutment.
| Device ID | K100360 |
| 510k Number | K100360 |
| Device Name: | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial, CO 80111 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR AMERICAS 13059 E PEAKVIEW AVE Centennial, CO 80111 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502019767 | K100360 | 000 |
| 09321502019514 | K100360 | 000 |
| 09321502019521 | K100360 | 000 |
| 09321502019538 | K100360 | 000 |
| 09321502019545 | K100360 | 000 |
| 09321502019552 | K100360 | 000 |
| 09321502019569 | K100360 | 000 |
| 09321502019576 | K100360 | 000 |
| 09321502019583 | K100360 | 000 |
| 09321502019590 | K100360 | 000 |
| 09321502014434 | K100360 | 000 |