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FDA 510(k) Application Details - K001800
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
510(K) Number
K001800
Device Name
Electromyograph, Diagnostic
Applicant
RJL ASSOCIATES, LLC.
86-3 BOSTON POST RD.
WATERFORD, CT 06385 US
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Contact
RONALD LUICH
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
06/14/2000
Decision Date
09/12/2000
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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