FDA 510(k) Application Details - K964250

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K964250
Device Name System, Digital Image Communications, Radiological
Applicant STERLING DIAGNOSTIC IMAGING, INC.
P.O. BOX 6101
BUILDING 600/MAILBOX 630
NEWARK, DE 19714-6101 US
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Contact JEAN E BARTLETT
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 10/24/1996
Decision Date 12/18/1996
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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