The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Bte Super-front Ppscl, Super-front Ppsc.
Device ID | K900829 |
510k Number | K900829 |
Device Name: | BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC |
Classification | Hearing Aid, Air Conduction |
Applicant | PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
Contact | D Huddleston |
Correspondent | D Huddleston PHONAK, INC. 850 E. DIEHL RD. BOX 3117 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 | 1990-02-21 |
Decision Date | 1990-05-23 |