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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K952080
Device Name CLARITY SYSTEM II
Applicant
SONAMED CORP.
306 MERRIAM ST.
WESTON,  MA  02193
Applicant Contact ALLISON DOLPHIN
Correspondent
SONAMED CORP.
306 MERRIAM ST.
WESTON,  MA  02193
Correspondent Contact ALLISON DOLPHIN
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received05/03/1995
Decision Date 09/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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