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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K140996
FOIA Releasable 510(k) K140996
Device Name MAMMI
Applicant
General Equipment For Medical Imaging (Oncovision-
Eduardo Peimo Yufera 3
Valencia,  ES 46012
Applicant Contact JOSE MONTES
Correspondent
Dekra Certification B.V
Utrechtseweg 310
Arnhem,  NL NL-6812 AR
Correspondent Contact J.A. VAN VUGT
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/17/2014
Decision Date 06/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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