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FDA 510(k) Application Details - K132236
Device Classification Name
Block, Beam-Shaping, Radiation Therapy
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510(K) Number
K132236
Device Name
Block, Beam-Shaping, Radiation Therapy
Applicant
.DECIMAL, INC.
121 CENTRAL PARK PLACE
SANFORD, FL 32771 US
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Contact
KIMBERLY RUPP
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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
07/18/2013
Decision Date
10/16/2013
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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