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FDA 510(k), K182010, ProgenaMatrix
FDA 510(k), K182010, ProgenaMatrix
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510(K) Number: K182010
Device Name: ProgenaMatrix
Manufacturer: Cell Constructs I, LLC
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 07/27/2018
Decision Date: 01/17/2019
Regulation Medical Specialty:
Device Name: ProgenaMatrix
Manufacturer: Cell Constructs I, LLC
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 07/27/2018
Decision Date: 01/17/2019
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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