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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K211542
Device Name PRIMO 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 Number892.1680
Classification Product Code
MQB  
Date Received05/19/2021
Decision Date 07/09/2021
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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