The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark Bone-anchored Hearing Aid (baha) System For Pediatric Use.
| Device ID | K984162 |
| 510k Number | K984162 |
| Device Name: | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-06-28 |
| Summary: | summary |