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FDA 510(k) Application Details - K042208
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K042208
Device Name
Electrode, Depth
Applicant
INOMED MEDIZINTECHNIK GMBH
KUNGSTENSGATAN 18, PO BX 7593
STOCKHOLM SE-103 93 DE
Other 510(k) Applications for this Company
Contact
ANDERS SKOGLUND
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2004
Decision Date
03/18/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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