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FDA 510(k) Application Details - K033452
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
510(K) Number
K033452
Device Name
Electromyograph, Diagnostic
Applicant
FASSTECH
76 TREBLE COVE RD.
BUILDING #2
NORTH BILLERICA, MA 01862 US
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Contact
LEE BRODY
Other 510(k) Applications for this Contact
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
IKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2003
Decision Date
11/28/2003
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
Y
Expedited Review
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