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FDA 510(k) Application Details - K001366
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K001366
Device Name
Source, Brachytherapy, Radionuclide
Applicant
PROSTEC LLC.
19526 EAST LAKE DR.
MIAMI, FL 33015 US
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Contact
AL WEISENBORN
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
03/31/2000
Decision Date
09/19/2000
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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