FDA 510(k) Application Details - K012385

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

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510(K) Number K012385
Device Name System, X-Ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact JOHN W JAECKLE
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 07/27/2001
Decision Date 08/10/2001
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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