The following data is part of a premarket notification filed by Entific Medical Systems, Inc. with the FDA for Branemark Bone-anchored Hearing Aid (baha) Cordelle Ii.
| Device ID | K992872 |
| 510k Number | K992872 |
| Device Name: | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | ENTIFIC MEDICAL SYSTEMS, INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Contact | Besty A Brown |
| Correspondent | Besty A Brown ENTIFIC MEDICAL SYSTEMS, INC. 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-26 |
| Decision Date | 1999-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502015752 | K992872 | 000 |
| 09321502015509 | K992872 | 000 |