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FDA 510(k) Application Details - K120613
Device Classification Name
More FDA Info for this Device
510(K) Number
K120613
Device Name
OEC 9900 ELITE
Applicant
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY, UT 84116 US
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Contact
GERALD BUSS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/29/2012
Decision Date
04/06/2012
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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