FDA 510(k) Application Details - K000770

Device Classification Name System, Image Processing, Radiological

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510(K) Number K000770
Device Name System, Image Processing, Radiological
Applicant CERNER CORP.
2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
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Contact SHELLEY LOOBY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/09/2000
Decision Date 05/16/2000
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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