FDA 510(k) Application Details - K973239

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K973239
Device Name System, Digital Image Communications, Radiological
Applicant ADAC LABORATORIES
540 ALDER DR.
MILPITAS, CA 95035 US
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Contact DENNIS W HENKELMAN
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 08/28/1997
Decision Date 11/26/1997
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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