510(k) Premarket Notification - U.S. Food and Drug Administration www.accessdata.fda.gov/.../pmn.cfm?ID... Food and Drug Administration May 22, 2015 - U.S. Department of Health and Human Services · FDA, U.S. Food and Drug ... Delta International Services & Logistics S.r.l. piazza cavour 17.
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 Correspodent Contact Mariella Giorgieri Regulation Number 882.5890 Classification Product Code GZJ Date Received 09/18/2014 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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