The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Ba310 Abutment, Bia310 Implant/abutment.
| Device ID | K182116 |
| 510k Number | K182116 |
| Device Name: | BA310 Abutment, BIA310 Implant/Abutment |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | Cochlear Americas 13059 E. Peakview Ave. Centennial, CO 80111 |
| Contact | Beth Murray |
| Correspondent | Beth Murray 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 | 2018-08-06 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502043939 | K182116 | 000 |
| 09321502043854 | K182116 | 000 |
| 09321502043892 | K182116 | 000 |
| 09321502043908 | K182116 | 000 |
| 09321502043861 | K182116 | 000 |
| 09321502043878 | K182116 | 000 |
| 09321502043885 | K182116 | 000 |
| 09321502043915 | K182116 | 000 |
| 09321502043922 | K182116 | 000 |
| 09321502043847 | K182116 | 000 |