FDA 510(k), K192705, MiniCap Extended Life PD Transfer Sets

FDA 510(k), K192705, MiniCap Extended Life PD Transfer Sets

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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: KXA
Date Received: 09/27/2019
Decision Date: 10/25/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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