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FDA 510(k) Application Details - K102349
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K102349
Device Name
System, X-Ray, Stationary
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK, NY 10017 US
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Contact
RUSSELL MUNVES
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2010
Decision Date
11/24/2010
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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