FDA 510(k) Application Details - K091889

Device Classification Name System, X-Ray, Stationary

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510(K) Number K091889
Device Name System, X-Ray, Stationary
Applicant CARESTREAM HEALTH, INC.
150 VERONA STREET
ROCHESTER, NY 14608 US
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Contact CAROLYN WAGNER
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 06/24/2009
Decision Date 07/20/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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