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FDA 510(k) Application Details - K062824
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K062824
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
ALPHA-OMEGA SERVICES, INC.
9156 ROSE ST
BELLFLOWER, CA 90706 US
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Contact
BOB A ROBNETT
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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
09/20/2006
Decision Date
07/03/2007
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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