FDA 510(k) Application Details - K022810

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K022810
Device Name Digitizer, Image, Radiological
Applicant RADIOGRAPHIC DIGITAL IMAGING, INC.
20406 EARL ST.
TORRANCE, CA 90503 US
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Contact ANALEI SAMASEIA
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 08/23/2002
Decision Date 10/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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