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FDA 510(k) Application Details - K991881
Device Classification Name
Source, Brachytherapy, Radionuclide
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510(K) Number
K991881
Device Name
Source, Brachytherapy, Radionuclide
Applicant
SOURCETECH MEDICAL, L.L.C.
295 E. LIES RD.
CAROL STREAM, IL 60188 US
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Contact
DAVID T SIERACKI
Other 510(k) Applications for this Contact
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
06/02/1999
Decision Date
03/16/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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