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FDA 510(k), K190185, Phasix ST Mesh with Open Positioning System
FDA 510(k), K190185, Phasix ST Mesh with Open Positioning System
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$149.00 USD
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510(K) Number: K190185
Device Name: Phasix ST Mesh with Open Positioning System
Manufacturer: C.R. Bard, Inc.
Device Classification Name: mesh, surgical, absorbable, abdominal hernia
Regulation Number: 878.3300
Classification Product Code: OWT
Date Received: 02/01/2019
Decision Date: 06/12/2019
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Phasix ST Mesh with Open Positioning System
Manufacturer: C.R. Bard, Inc.
Device Classification Name: mesh, surgical, absorbable, abdominal hernia
Regulation Number: 878.3300
Classification Product Code: OWT
Date Received: 02/01/2019
Decision Date: 06/12/2019
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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