The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Behind-the-ear Hearing Aid Model 404 Pp-pc.
| Device ID | K891247 |
| 510k Number | K891247 |
| Device Name: | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC |
| Classification | Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
| Contact | L Branderbit |
| Correspondent | L Branderbit SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
| Product Code | ESF |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-03-29 |