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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 K964224
Device Name STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact EDWARD F VALDEZ
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact EDWARD F VALDEZ
Regulation Number882.1310
Classification Product Code
GYC  
Date Received10/23/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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