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FDA 510(k) Application Details - K093588
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K093588
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
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
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2009
Decision Date
01/11/2010
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
Y
Expedited Review
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