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FDA 510(k) Application Details - K132463
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K132463
Device Name
Marker, Radiographic, Implantable
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
878.4300
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Classification Product Code
NEU
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More FDA Info for this Product Code
Date Received
08/07/2013
Decision Date
12/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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