FDA 510(k) Application Details - K083725

Device Classification Name

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510(K) Number K083725
Device Name RADPRO ION
Applicant VIRTUAL IMAGING, INC.
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number

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Classification Product Code OWB
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Date Received 12/15/2008
Decision Date 01/22/2009
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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