The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cordelle Ii Sound Processor.
| Device ID | K150751 |
| 510k Number | K150751 |
| Device Name: | Cordelle II Sound Processor |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 E PEAKVIEW AVENUE Centennial, CO 80111 |
| Contact | Laura Blair |
| Correspondent | Laura Blair COCHLEAR AMERICAS 13059 E PEAKVIEW AVENUE 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 | 2015-03-23 |
| Decision Date | 2015-07-22 |
| Summary: | summary |