The following data is part of a premarket notification filed by Entific Medical Systems, Inc. with the FDA for Bilateral Fitting Of The Branemark Bone-anchored Hearing Aid (baha) System..
| Device ID | K011438 |
| 510k Number | K011438 |
| Device Name: | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance Bundy |
| Correspondent | Constance Bundy ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-10 |
| Decision Date | 2001-07-23 |