The following data is part of a premarket notification filed by Phonak Llc with the FDA for Lyric2.
Device ID | K130790 |
510k Number | K130790 |
Device Name: | LYRIC2 |
Classification | Hearing Aid, Air Conduction |
Applicant | PHONAK LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Contact | John J Smith |
Correspondent | John J Smith PHONAK LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-22 |
Decision Date | 2013-06-27 |
Summary: | summary |