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FDA 510(k) Application Details - K961013
Device Classification Name
Electrode, Needle, Diagnostic Electromyograph
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510(K) Number
K961013
Device Name
Electrode, Needle, Diagnostic Electromyograph
Applicant
MEDELEC INTL. CORP.
MANOR WAY
OLD WOKING, SURREY GU22 9JU
ENGLAND GB
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Contact
JEFF HALL
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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
03/13/1996
Decision Date
12/20/1996
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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