FDA 510(k) Application Details - K133278

Device Classification Name

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510(K) Number K133278
Device Name DISCOVERY IGS 740
Applicant GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
BUC 78530 FR
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Contact MICHEL GENUER
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Regulation Number

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Classification Product Code OWB
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Date Received 10/24/2013
Decision Date 04/24/2014
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 N
Expedited Review



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