IN-THE-EAR HEARING AID, MODEL CE-3

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 In-the-ear Hearing Aid, Model Ce-3.

Pre-market Notification Details

Device IDK780309
510k NumberK780309
Device Name:IN-THE-EAR HEARING AID, MODEL CE-3
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-02-23
Decision Date1978-02-28

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