SOUNDCHOICE WITH VARIABLE SLOPE

Hearing Aid, Air Conduction

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soundchoice With Variable Slope.

Pre-market Notification Details

Device IDK926476
510k NumberK926476
Device Name:SOUNDCHOICE WITH VARIABLE SLOPE
ClassificationHearing Aid, Air Conduction
Applicant BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie,  MN  55344
ContactMartin
CorrespondentMartin
BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-29
Decision Date1993-02-02

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