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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K140340
Device Name SKINTACT
Applicant
Leonhard Lang GmbH
P.O. Box 560
Stillwater,  MN  55082 -0560
Applicant Contact ELAINE DUNCAN
Correspondent
Leonhard Lang GmbH
P.O. Box 560
Stillwater,  MN  55082 -0560
Correspondent Contact ELAINE DUNCAN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/11/2014
Decision Date 05/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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