The following data is part of a premarket notification filed by Cochlear Bone Anchored Systems Ab with the FDA for Baha Cordelle Ii.
| Device ID | K080363 |
| 510k Number | K080363 |
| Device Name: | BAHA CORDELLE II |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | COCHLEAR BONE ANCHORED SYSTEMS AB 400 INVERNESS PARKWAY SUITE 400 Englewood, CO 80112 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR BONE ANCHORED SYSTEMS AB 400 INVERNESS PARKWAY SUITE 400 Englewood, CO 80112 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-04-10 |
| Summary: | summary |