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FDA 510(k) Application Details - K033052
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K033052
Device Name
Media, Electroconductive
Applicant
COMPUMEDICS USA, LTD.
7850 PASEO DEL NORTE
EL PASO, TX 79912 US
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Contact
ELVIRA GARCIA
Other 510(k) Applications for this Contact
Regulation Number
882.1275
More FDA Info for this Regulation Number
Classification Product Code
GYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2003
Decision Date
12/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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