EUROSTAR SUPER, EUROSTAR VFC

Hearing Aid, Air Conduction

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Eurostar Super, Eurostar Vfc.

Pre-market Notification Details

Device IDK942036
510k NumberK942036
Device Name:EUROSTAR SUPER, EUROSTAR VFC
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. Eden Prairie,  MN  55344
ContactRick Stromberg
CorrespondentRick Stromberg
STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-28
Decision Date1994-06-24

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