FDA 510(k) Application Details - K060210

Device Classification Name System, Image Processing, Radiological

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510(K) Number K060210
Device Name System, Image Processing, Radiological
Applicant MAXANT TECHNOLOGIES, INC.
7540 CALDWELL AVE
NILES, IL 60714 US
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Contact DONALD P DEVALE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/27/2006
Decision Date 02/10/2006
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 Y
Expedited Review



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