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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 K133782
Device Name NOVA FA DR SYSTEM
Applicant
SEDECAL SA
8870 RAVELLO CT.
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
SEDECAL SA
8870 RAVELLO CT.
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/12/2013
Decision Date 03/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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