FDA 510(k) Application Details - K960575

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K960575
Device Name System, X-Ray, Angiographic
Applicant GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE, WI 53201 US
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Contact LARRY A KROGER, PH.D.
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 02/12/1996
Decision Date 05/07/1996
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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