FDA 510(k) Application Details - K140033

Device Classification Name System, Image Processing, Radiological

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510(K) Number K140033
Device Name System, Image Processing, Radiological
Applicant CONVERGENT LIFE SCIENCES, INC.
2377 GOLD MEADOW WAY
SUITE 160
GOLD RIVER, CA 95670 US
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Contact DINESH KUMAR
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/07/2014
Decision Date 02/27/2014
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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