FDA 510(k) Application Details - K964224

Device Classification Name Electrode, Cortical

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510(K) Number K964224
Device Name Electrode, Cortical
Applicant PMT CORP.
1500 PARK RD.
CHANHASSEN, MN 55317 US
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Contact EDWARD F VALDEZ
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Regulation Number 882.1310

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Classification Product Code GYC
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Date Received 10/23/1996
Decision Date 03/19/1997
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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