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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
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