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FDA 510(k) Application Details - K071399
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
More FDA Info for this Device
510(K) Number
K071399
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
SICEL TECHNOLOGIES, INC.
3800 GATEWAY CENTRE BLVD.
SUITE 308
MORRISVILLE, NC 27560 US
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Contact
TAMMY B CARREA
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
LHN
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More FDA Info for this Product Code
Date Received
05/21/2007
Decision Date
06/20/2007
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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