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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(K) Number K122876
Device Name MULTIFLEX TINNITUS TECHNOLOGY
Applicant
STARKEY LABORATORIES
6600-6700 washington ave so.
eden prairie,  MN  55344
Contact ken meyer
Regulation Number874.3400
Classification Product Code
KLW  
Date Received09/19/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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