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FDA 510(k), K143484, BioZorb Marker
FDA 510(k), K143484, BioZorb Marker
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510(K) Number: K143484
Device Name: BioZorb Marker
Manufacturer: FOCAL THERAPEUTICS
Device Classification Name: marker, radiographic, implantable
Regulation Number: 878.4300
Classification Product Code: NEU
Date Received: 12/08/2014
Decision Date: 06/29/2015
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BioZorb Marker
Manufacturer: FOCAL THERAPEUTICS
Device Classification Name: marker, radiographic, implantable
Regulation Number: 878.4300
Classification Product Code: NEU
Date Received: 12/08/2014
Decision Date: 06/29/2015
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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