BAHA DIVINO
Hearing Aid, Bone Conduction
ENTIFIC MEDICAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Entific Medical Systems, Inc. with the FDA for Baha Divino.
Pre-market Notification Details
| Device ID | K042017 |
| 510k Number | K042017 |
| Device Name: | BAHA DIVINO |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G 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 | 2004-07-27 |
| Decision Date | 2004-08-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502034067 | K042017 | 000 |
| 09321502033428 | K042017 | 000 |
| 09321502033411 | K042017 | 000 |
| 09321502033404 | K042017 | 000 |
| 09321502033398 | K042017 | 000 |
| 09321502016292 | K042017 | 000 |
Trademark Results [BAHA DIVINO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAHA DIVINO 79034390 3436247 Dead/Cancelled |
Cochlear Bone Anchored Solutions AB 2005-08-26 |
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