FDA 510(k) Application Details - K011049

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K011049
Device Name Digitizer, Image, Radiological
Applicant VIDAR SYSTEMS CORP.
460 SPRING PARK PL.
HERNDON, VA 20170 US
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Contact MARY HARP
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 04/06/2001
Decision Date 10/01/2001
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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