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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K142666
Device Name Scrambler Therapy MC-5 A Device
Applicant
Delta International Services & Logistics S.R.L
Piazza Cavour 17
Rome,  IT 00193
Applicant Contact Donatella Ruscito
Correspondent
Delta International Services & Logistics S.R.L
Piazza Adriana 4
Rome,  IT 00193
Correspondent Contact Mariella Giorgieri
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/18/2014
Decision Date 05/22/2015
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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