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FDA 510(k) Application Details - K060314
Device Classification Name
System, Radiation Therapy, Radionuclide
More FDA Info for this Device
510(K) Number
K060314
Device Name
System, Radiation Therapy, Radionuclide
Applicant
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DRIVE
SUITE A-1
SAN DIEGO, CA 92128 US
Other 510(k) Applications for this Company
Contact
DAN OLIVIER
Other 510(k) Applications for this Contact
Regulation Number
892.5750
More FDA Info for this Regulation Number
Classification Product Code
IWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2006
Decision Date
04/06/2006
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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