FDA 510(k) Application Details - K033193

Device Classification Name Goniometer With Electrodes

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510(K) Number K033193
Device Name Goniometer With Electrodes
Applicant FRIENDLY SENSORS AG
719 A STREET, NE
WASHINGTON, DC 20002 US
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Contact TRISH LANDRY
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Regulation Number 888.1500

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Classification Product Code NKI
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Date Received 10/02/2003
Decision Date 01/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K033193


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