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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K182086
Device Name ARCO FP
Applicant
A.T.S. Applicazione Tecnologie Speciali s.r.l.
Via A. Volta, n.10
Torre de’ Roveri,  IT 24060
Applicant Contact Duilio Finazzi
Correspondent
Thema s.r.l.
Via Saragat 5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
OXO  
Date Received08/02/2018
Decision Date 08/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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