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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name goniometer with electrodes
510(k) Number K033193
Device Name SONOSENS
Applicant
FRIENDLY SENSORS AG
719 A STREET, NE
WASHINGTON,  DC  20002
Applicant Contact TRISH LANDRY
Correspondent
FRIENDLY SENSORS AG
719 A STREET, NE
WASHINGTON,  DC  20002
Correspondent Contact TRISH LANDRY
Regulation Number888.1500
Classification Product Code
NKI  
Date Received10/02/2003
Decision Date 01/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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