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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 K130883
Device Name SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
Applicant
SEDECAL SA
C/PELAYA, 9-13, POL. IND.
RIO DE JANEIRO
ALGETE, MADRID,  ES 28110
Applicant Contact LUISA GOMEZ DE AGUERO
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/29/2013
Decision Date 04/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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