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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K110260
Device Name NEWTOM 5G / NEWTOM 5G VERSION FP
Applicant
Qr S.R.L.
Via Silvestrini 20
Verona,  IT 37135
Applicant Contact LORENZO BORTOLOTTI
Correspondent
Qr S.R.L.
Via Silvestrini 20
Verona,  IT 37135
Correspondent Contact LORENZO BORTOLOTTI
Regulation Number892.1750
Classification Product Code
OAS  
Date Received01/28/2011
Decision Date 04/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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