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FDA 510(k), K183205, PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
FDA 510(k), K183205, PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
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$149.00 USD
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510(K) Number: K183205
Device Name: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Manufacturer: Patrick Pennie
Device Classification Name: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation Number: JQC
Classification Product Code: 11/19/2018
Date Received: 05/30/2019
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Hematology
Device Name: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Manufacturer: Patrick Pennie
Device Classification Name: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation Number: JQC
Classification Product Code: 11/19/2018
Date Received: 05/30/2019
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Hematology
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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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