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FDA 510(k) Application Details - K142701
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K142701
Device Name
Source, Brachytherapy, Radionuclide
Applicant
Salutaris Medical Devices, Inc.
4330 N Campbell Ave, Suite 250
Tucson, AZ 85718 US
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Contact
Laurence Marsteller
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
09/22/2014
Decision Date
12/19/2014
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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