FDA 510(k) Application Details - K141475

Device Classification Name System, Image Processing, Radiological

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510(K) Number K141475
Device Name System, Image Processing, Radiological
Applicant THERENVA SAS
2 RUE HENRI LE GUILLOUX
RENNES 35000 FR
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Contact CEMIL GOKSU
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/04/2014
Decision Date 07/31/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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