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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 St. NE
Washington,  DC  20002
Applicant Contact TRISH LANDRY
Correspondent
Friendly Sensors AG
719 A St. 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
Predetermined Change
Control Plan Authorized		 No
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