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FDA 510(k), K192705, MiniCap Extended Life PD Transfer Sets
FDA 510(k), K192705, MiniCap Extended Life PD Transfer Sets
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$149.00 USD
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510(K) Number: K192705
Device Name: MiniCap Extended Life PD Transfer Sets
Manufacturer: Kimberly Garcia
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: 09/27/2019
Date Received: 10/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MiniCap Extended Life PD Transfer Sets
Manufacturer: Kimberly Garcia
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: 09/27/2019
Date Received: 10/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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