The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Phonica Model 312-sc Ite Hearing Instrument.
| Device ID | K912571 |
| 510k Number | K912571 |
| Device Name: | PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville, IL 60566 |
| Contact | Bill Lesiecki |
| Correspondent | Bill Lesiecki PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville, IL 60566 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-06-26 |