PRECISE IMPRESSION KIT

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 Precise Impression Kit.

Pre-market Notification Details

Device IDK970952
510k NumberK970952
Device Name:PRECISE IMPRESSION KIT
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie,  MN  55344
ContactShari L Swiden
CorrespondentShari L Swiden
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 Received1997-03-14
Decision Date1997-05-02
Summary:summary

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