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FDA 510(k) Application Details - K130763
Device Classification Name
Marker, Radiographic, Implantable
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510(K) Number
K130763
Device Name
Marker, Radiographic, Implantable
Applicant
SCION MEDICAL TECHNOLOGIES LLC
23879 BLUE SPRUCE RD
SAUK CENTRE, MN 56378 US
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Contact
JOSEPH OSTENDORF
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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
03/20/2013
Decision Date
05/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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