FDA 510(k) Application Details - K980220

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K980220
Device Name System, Digital Image Communications, Radiological
Applicant STERLING DIAGNOSTIC IMAGING, INC.
10 SOUTH ACADEMY ST.
MAIL DROP 120
GREENVILLE, SC 29601 US
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Contact TIMOTHY W CAPEHART
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 01/22/1998
Decision Date 02/13/1998
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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