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FDA 510(k) Application Details - K000475
Device Classification Name
Source, Brachytherapy, Radionuclide
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510(K) Number
K000475
Device Name
Source, Brachytherapy, Radionuclide
Applicant
DRAXIMAGE, INC.
16751 TRANS CANADA HIGHWAY
KIRKLAND, QC H9H 4J4 CA
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Contact
R.J. FLANAGAN
Other 510(k) Applications for this Contact
Regulation Number
892.5730
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Classification Product Code
KXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2000
Decision Date
08/22/2000
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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