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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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More FDA Info for this Product Code
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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