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FDA 510(k) Application Details - K130426
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
More FDA Info for this Device
510(K) Number
K130426
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
SUMITOMO HEAVY INDUSTRIES, LTD
11440 W. BERNARDO COURT
SUITE 300
SAN DIEGO, CA 92127 US
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Contact
RONALD S WARREN
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
LHN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/2013
Decision Date
11/19/2013
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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