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FDA 510(k) Application Details - K032761
Device Classification Name
More FDA Info for this Device
510(K) Number
K032761
Device Name
KMC-950 C-ARM MOBILE SYSTEM
Applicant
UNITED RADIOLOGY SYSTEMS, INC.
151 SOUTH PFINGSTEN RD.
UNIT T
DEERFIELD, IL 60015 US
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Contact
JOHN W LEE
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2003
Decision Date
05/14/2004
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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