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FDA 510(k), K190268, Hydrofera Blue READY - Border
FDA 510(k), K190268, Hydrofera Blue READY - Border
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510(K) Number: K190268
Device Name: Hydrofera Blue READY - Border
Manufacturer: Hydrofera, LLC
Device Classification Name: Dressing, Wound, Drug
Regulation Number:
Classification Product Code: FRO
Date Received: 02/08/2019
Decision Date: 11/06/2019
Regulation Medical Specialty:
Device Name: Hydrofera Blue READY - Border
Manufacturer: Hydrofera, LLC
Device Classification Name: Dressing, Wound, Drug
Regulation Number:
Classification Product Code: FRO
Date Received: 02/08/2019
Decision Date: 11/06/2019
Regulation Medical Specialty:
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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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