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FDA 510(k) Application Details - K013875
Device Classification Name
Block, Beam-Shaping, Radiation Therapy
More FDA Info for this Device
510(K) Number
K013875
Device Name
Block, Beam-Shaping, Radiation Therapy
Applicant
MED-TEC,INC.
1401 8TH ST. S.E.
P.O. BOX 320
ORANGE CITY, IA 51041 US
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Contact
DONALD F RIIBE
Other 510(k) Applications for this Contact
Regulation Number
892.5710
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Classification Product Code
IXI
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More FDA Info for this Product Code
Date Received
11/23/2001
Decision Date
09/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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