The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Audiant Bone Conductor W/improved Aa Coil.
| Device ID | K861971 |
| 510k Number | K861971 |
| Device Name: | XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Don Bruce |
| Correspondent | Don Bruce XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-21 |
| Decision Date | 1986-05-30 |