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FDA 510(k) Application Details - K101686
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K101686
Device Name
System, X-Ray, Stationary
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD, CT 06902-6300 US
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Contact
DEBBIE PEACOCK
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
06/16/2010
Decision Date
10/29/2010
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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