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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K862799
Device Name SKIN PURE
Applicant
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact DIANA BEAL
Correspondent
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact DIANA BEAL
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/22/1986
Decision Date 11/13/1986
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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