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FDA 510(k) Application Details - K040553
Device Classification Name
Block, Beam-Shaping, Radiation Therapy
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510(K) Number
K040553
Device Name
Block, Beam-Shaping, Radiation Therapy
Applicant
DIREX SYSTEMS CORP.
11 MERCER RD.
BUSINESS PARK
NATICK, MA 01760 US
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Contact
LARISA GERSHTEIN
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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
03/02/2004
Decision Date
04/01/2004
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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