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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 K211777
Device Name ARCO FP-S
Applicant
A.T.S. Applicazione Tecnologie Speciali S.R.L.
Via Alessandro Volta, 10
Torre De Roveri,  IT 24060
Applicant Contact Livia Pillitteri
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
OXO  
Date Received06/09/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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