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FDA 510(k) Application Details - K080791
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K080791
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
SENORX, INC.
11 COLUMBIA
ALISO VIEJO, CA 92656 US
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Contact
EBEN GORDON
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Regulation Number
892.5700
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Classification Product Code
JAQ
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More FDA Info for this Product Code
Date Received
03/20/2008
Decision Date
04/30/2008
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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