The following data is part of a premarket notification filed by Cochlear Bone Anchored Systems Ab with the FDA for Cochlear Baha Bp100.
| Device ID | K090720 |
| 510k Number | K090720 |
| Device Name: | COCHLEAR BAHA BP100 |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR BONE ANCHORED SYSTEMS AB 13059 E. PEAKVIEW AVE. Centennial, CO 80111 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR BONE ANCHORED SYSTEMS AB 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 | 2009-03-18 |
| Decision Date | 2009-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502040242 | K090720 | 000 |
| 09321502012829 | K090720 | 000 |
| 09321502015400 | K090720 | 000 |
| 09321502015912 | K090720 | 000 |
| 09321502016032 | K090720 | 000 |
| 09321502020657 | K090720 | 000 |
| 09321502020800 | K090720 | 000 |
| 09321502040051 | K090720 | 000 |
| 09321502040068 | K090720 | 000 |
| 09321502043748 | K090720 | 000 |
| 09321502034371 | K090720 | 000 |
| 09321502040235 | K090720 | 000 |
| 09321502020695 | K090720 | 000 |
| 09321502036030 | K090720 | 000 |
| 09321502016681 | K090720 | 000 |
| 09321502016698 | K090720 | 000 |
| 09321502016704 | K090720 | 000 |
| 09321502016711 | K090720 | 000 |
| 09321502012812 | K090720 | 000 |