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Re: None

Wednesday, 05/11/2016 1:41:23 AM

Wednesday, May 11, 2016 1:41:23 AM

Post# of 15274
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142666

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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