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510(k) K982818

HOSPAL TIPSTOP by Gambro Healthcare — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1998
Date Received
August 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
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)
  • K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (November 4, 1998)
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  • 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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