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FDA 510(k), K161424, Phasix Mesh
FDA 510(k), K161424, Phasix Mesh
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$149.00 USD
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510(K) Number: K161424
Device Name: Phasix Mesh
Manufacturer: C.R. BARD INC.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 05/23/2016
Decision Date: 09/29/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Phasix Mesh
Manufacturer: C.R. BARD INC.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 05/23/2016
Decision Date: 09/29/2016
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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