FDA 510(k) Application Details - K151790

Device Classification Name Electrode, Depth

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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
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Regulation Number 882.1330

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Classification Product Code GZL
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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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