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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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