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FDA 510(k) Application Details - K101508
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
More FDA Info for this Device
510(K) Number
K101508
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
ION BEAM APPLICATIONS S.A.
1500 MARKET STREET
CENTRE SQUARE WEST, 38TH FLOOR
PHILADELPHIA, PA 19102 US
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Contact
JOHN B REISS
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
06/01/2010
Decision Date
08/06/2010
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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