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510(k) K974899

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H by Gambro Healthcare — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1998
Date Received
December 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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  • K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KI (February 24, 1999)
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  • K982818 — HOSPAL TIPSTOP (October 21, 1998)
  • K981681 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (August 11, 1998)
  • K981085 — GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM (May 18, 1998)
  • K970253 — COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (September 26, 1997)

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