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FDA 510(k) Application Details - K983597
Device Classification Name
Electrode, Needle
More FDA Info for this Device
510(K) Number
K983597
Device Name
Electrode, Needle
Applicant
MEDICOTEST, INC.
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 US
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Contact
EMALEE G MURPHY
Other 510(k) Applications for this Contact
Regulation Number
882.1350
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Classification Product Code
GXZ
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More FDA Info for this Product Code
Date Received
10/13/1998
Decision Date
01/11/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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