FDA 510(k) Application Details - K053039

Device Classification Name System, Image Processing, Radiological

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510(K) Number K053039
Device Name System, Image Processing, Radiological
Applicant CLINTON ELECTRONICS CORP.
6701 CLINTON ROAD
LOVES PARK, IL 61111 US
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Contact RANDALL J SCHROEDL
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/27/2005
Decision Date 03/01/2006
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 N
Expedited Review



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