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FDA 510(k) Application Details - K092405
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K092405
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01750 US
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Contact
JENNIFER SULLIVAN
Other 510(k) Applications for this Contact
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
08/06/2009
Decision Date
08/27/2009
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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