FDA 510(k) Application Details - K973368

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K973368
Device Name System, X-Ray, Angiographic
Applicant GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact LARRY A KROGER
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 09/08/1997
Decision Date 10/17/1997
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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