FDA 510(k) Application Details - K141356

Device Classification Name Marker, Radiographic, Implantable

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510(K) Number K141356
Device Name Marker, Radiographic, Implantable
Applicant WILSON-COOK MEDICAL INC.
4900 Bethania Station Rd
Winston Salem, NC 27105 US
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Contact MARGE WALLS-WALKER
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Regulation Number 878.4300

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Classification Product Code NEU
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Date Received 05/23/2014
Decision Date 06/20/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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