FDA 510(k) Application Details - K120910

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K120910
Device Name System, X-Ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS SCS
283, RUE DE LA MINIERE
BUC 78530 FR
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Contact STEPHEN SLAVENS
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 03/26/2012
Decision Date 06/18/2012
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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