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510(k) K070414

GAMBRO CARTRIDGE BLOOD SETS by Gambro Renal Products — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2007
Date Received
February 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
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