FDA 510(k) Application Details - K083503

Device Classification Name System, X-Ray, Stationary

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510(K) Number K083503
Device Name System, X-Ray, Stationary
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN, CA 92781-2068 US
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Contact PAUL BIGGINS
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 11/26/2008
Decision Date 02/13/2009
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 Y
Expedited Review



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