FDA 510(k) Application Details - K973090

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K973090
Device Name System, Digital Image Communications, Radiological
Applicant PROGRAM S.R.L.
719 CATALPA AVE.
TEANECK, NJ 07666 US
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Contact DIANA UPTON
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 08/18/1997
Decision Date 10/28/1997
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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