FDA 510(k), K113202, TISSUE MARKER

FDA 510(k), K113202, TISSUE MARKER

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510(K) Number: K113202
Device Name: TISSUE MARKER
Manufacturer: FOCAL THERAPEUTICS
Device Classification Name: marker, radiographic, implantable
Regulation Number: 878.4300
Classification Product Code: NEU
Date Received: 10/31/2011
Decision Date: 02/28/2012
Regulation Medical Specialty: General & Plastic Surgery

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