FDA 510(k) Application Details - K050704

Device Classification Name System, X-Ray, Stationary

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510(K) Number K050704
Device Name System, X-Ray, Stationary
Applicant GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact JOHN L SCHMIDT
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 03/18/2005
Decision Date 04/08/2005
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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