The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soundchoice With Variable Slope.
Device ID | K926476 |
510k Number | K926476 |
Device Name: | SOUNDCHOICE WITH VARIABLE SLOPE |
Classification | Hearing Aid, Air Conduction |
Applicant | BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie, MN 55344 |
Contact | Martin |
Correspondent | Martin BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie, MN 55344 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-29 |
Decision Date | 1993-02-02 |