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FDA 510(k) Application Details - K023147
Device Classification Name
Electromyograph, Diagnostic
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510(K) Number
K023147
Device Name
Electromyograph, Diagnostic
Applicant
BORTEC BIOMEDICAL, LTD.
936-11TH AVENUE EAST
SEATTLE, WA 98102 US
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Contact
CARL YOUNGMAN
Other 510(k) Applications for this Contact
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
09/20/2002
Decision Date
12/12/2002
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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