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FDA 510(k) Application Details - K081677
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K081677
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
CIANNA MEDICAL, INC.
6 JOURNEY
SUITE 125
ALISO VIEJO, CA 92656 US
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Contact
GARY MOCNIK
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
06/17/2008
Decision Date
07/22/2008
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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