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FDA 510(k) Application Details - K020907
Device Classification Name
Electrode, Needle, Diagnostic Electromyograph
More FDA Info for this Device
510(K) Number
K020907
Device Name
Electrode, Needle, Diagnostic Electromyograph
Applicant
MEDICOTEST A/S
1800 MASSCHUSETTS AVE., N.W.
SUITE 200
WASHINGTON, DC 20036-1221 US
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Contact
EMALEE G MURPHY
Other 510(k) Applications for this Contact
Regulation Number
890.1385
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Classification Product Code
IKT
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More FDA Info for this Product Code
Date Received
03/20/2002
Decision Date
06/14/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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