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FDA 510(k) Application Details - K053358
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K053358
Device Name
Electrode, Depth
Applicant
AD-TECH MEDICAL INSTRUMENT CORP.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact
Gary Syring
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
12/02/2005
Decision Date
05/25/2006
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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