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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K151790
FOIA Releasable 510(k) K151790
Device Name PMT Platinum Depthalon Depth Electrode
Applicant
Pmt Corporation
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact KIM SCHMELZER
Correspondent
Pmt Corporation
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact KIM SCHMELZER
Regulation Number882.1330
Classification Product Code
GZL  
Date Received07/01/2015
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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