FDA 510(k) Application Details - K000630

Device Classification Name System, Image Processing, Radiological

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510(K) Number K000630
Device Name System, Image Processing, Radiological
Applicant HOPKINS IMAGING SYSTEMS, INC.
1812 FLOWER ST.
DUARTE, CA 91010 US
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Contact RICHARD HOPKINS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 02/24/2000
Decision Date 05/12/2000
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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