FDA 510(k), K191564, Progenikine Concentrating System 25 mL System
FDA 510(k), K191564, Progenikine Concentrating System 25 mL System
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510(K) Number: K191564
Device Name: Progenikine Concentrating System 25 mL System
Manufacturer: Emcyte Corporation
Device Classification Name: system, suction, lipoplasty
Regulation Number: 878.5040
Classification Product Code: MUU
Date Received: 06/13/2019
Decision Date: 11/07/2019
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Progenikine Concentrating System 25 mL System
Manufacturer: Emcyte Corporation
Device Classification Name: system, suction, lipoplasty
Regulation Number: 878.5040
Classification Product Code: MUU
Date Received: 06/13/2019
Decision Date: 11/07/2019
Regulation Medical Specialty: General & Plastic Surgery
- 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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