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510(k) K925522

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION by C.G.H. Medical, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
November 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by C.G.H. Medical, Inc.

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  • K933818 — GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (January 25, 1995)
  • K920757 — FILTRAL HEMODIALYZERS (August 5, 1994)
  • K931720 — LUNDIA ALPHA 700 HEMODIALYZER (July 7, 1994)
  • K924437 — HEMOSPAL KIT B22 / MULTIFLOW 60 KIT (June 27, 1994)
  • K940601 — GAMBRO BICART 720G (March 22, 1994)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)
  • K914271 — GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (April 13, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K911603 — HEMOSPAL KIT B22 (August 7, 1991)

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