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FDA 510(k) Application Details - K973355
Device Classification Name
Electromyograph, Diagnostic
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510(K) Number
K973355
Device Name
Electromyograph, Diagnostic
Applicant
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
100 COLLIP CIRCLE, #100
LONDON N6G 4X8 CA
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Contact
ROBERT SNOW
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Regulation Number
890.1375
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Classification Product Code
IKN
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More FDA Info for this Product Code
Date Received
09/08/1997
Decision Date
12/05/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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