STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES

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 Star 22,33,66 Series & Starkey H. And Sm Series.

Pre-market Notification Details

Device IDK880969
510k NumberK880969
Device Name:STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie,  MN  55344
ContactKeith Guggenberger
CorrespondentKeith Guggenberger
STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-08
Decision Date1988-04-11

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