The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Pico-forte Sc-2.
Device ID | K932734 |
510k Number | K932734 |
Device Name: | PHONAK PICO-FORTE SC-2 |
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 | 1993-06-07 |
Decision Date | 1993-07-27 |