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FDA 510(k) Application Details - K151790
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K151790
Device Name
Electrode, Depth
Applicant
PMT CORPORATION
1500 PARK RD
CHANHASSEN, MN 55317 US
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Contact
KIM SCHMELZER
Other 510(k) Applications for this Contact
Regulation Number
882.1330
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Classification Product Code
GZL
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More FDA Info for this Product Code
Date Received
07/01/2015
Decision Date
07/14/2016
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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