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FDA 510(k) Application Details - K002147
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K002147
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
SUITE 100
ST. LOUIS, MO 63132-1716 US
Other 510(k) Applications for this Company
Contact
MICHAEL A PARSONS
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
07/17/2000
Decision Date
10/13/2000
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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