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FDA 510(k) Application Details - K061638
Device Classification Name
Source, Brachytherapy, Radionuclide
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510(K) Number
K061638
Device Name
Source, Brachytherapy, Radionuclide
Applicant
BEST MEDICAL INTERNATIONAL, INC.
7643 FULLERTON RD.
SPRINGFIELD, VA 22153 US
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Contact
MICHAEL J PHELAN
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Regulation Number
892.5730
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Classification Product Code
KXK
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More FDA Info for this Product Code
Date Received
06/12/2006
Decision Date
08/04/2006
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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