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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 K920674
Device Name ELECTROLINK
Applicant
Kold Products
2026 Sterling Ave.
Elkhart,  IN  46516
Applicant Contact JOHN LEVY
Correspondent
Kold Products
2026 Sterling Ave.
Elkhart,  IN  46516
Correspondent Contact JOHN LEVY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/14/1992
Decision Date 01/28/1993
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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