CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7

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 Custom I.t.e. Hearing Aids Ce-5, Ce-6, Ce-7.

Pre-market Notification Details

Device IDK880333
510k NumberK880333
Device Name:CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
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 Received1988-01-26
Decision Date1988-03-18

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