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FDA 510(k) Application Details - K993766
Device Classification Name
System,Planning,Radiation Therapy Treatment
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510(K) Number
K993766
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
HELAX AB
447 MARCH ROAD
KANATA ONTARIO K2K 1X8 CA
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Contact
E.S. MARTELL
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
MUJ
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More FDA Info for this Product Code
Date Received
11/08/1999
Decision Date
12/08/1999
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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