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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrode, Cortical
510(k) Number K082474
Device Name PMT SUBDURAL CORTICAL ELECTRODES
Applicant
PMT CORP.
1500 PARK RD.
CHANHASSEN,  MN  55317
Applicant Contact ERIC CAILLE
Correspondent
PMT CORP.
1500 PARK RD.
CHANHASSEN,  MN  55317
Correspondent Contact ERIC CAILLE
Regulation Number882.1310
Classification Product Code
GYC  
Date Received08/28/2008
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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