FDA 510(k) Application Details - K072219

Device Classification Name Marker, Radiographic, Implantable

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510(K) Number K072219
Device Name Marker, Radiographic, Implantable
Applicant CYTOPHIL INC
5546 N SANTA MONICA BLVD
WHITEFISH BAY, WI 53217-5159 US
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Contact Greg Johnson
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Regulation Number 878.4300

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Classification Product Code NEU
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Date Received 08/10/2007
Decision Date 01/18/2008
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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