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FDA 510(k) Application Details - K092822
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K092822
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
VIVARAY, INC.
3264 ALPINE ROAD
PORTOLA VALLEY, CA 94028 US
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Contact
GEORGE HERMANN
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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
09/14/2009
Decision Date
11/03/2009
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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