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FDA 510(k) Application Details - K051022
Device Classification Name
System, Radiation Therapy, Radionuclide
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510(K) Number
K051022
Device Name
System, Radiation Therapy, Radionuclide
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM SE-103 93 SE
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Contact
PETER LOWENDAHL
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Regulation Number
892.5750
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Classification Product Code
IWB
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More FDA Info for this Product Code
Date Received
04/22/2005
Decision Date
06/01/2005
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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