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FDA 510(k) Application Details - K032278
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K032278
Device Name
Electrode, Cutaneous
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM, MD 21090-1356 US
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Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
882.1320
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Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
07/24/2003
Decision Date
03/05/2004
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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