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510(k) K230193

Servator P Plus SALF Solution by S.A.L.F. Spa — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2023
Date Received
January 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by S.A.L.F. Spa

  • K211842 — Servator M SALF Solution (December 20, 2021)
  • K202652 — Servator P SALF Solution with THAM (August 19, 2021)
  • K190063 — Servator C SALF Solution (August 14, 2019)
  • K180481 — Servator B SALF Solution (June 29, 2018)
  • K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml (October 20, 2017)

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