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510(k) K990159

DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 by Dynamic Technology Corp. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1999
Date Received
January 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dynamic Technology Corp.

  • K011537 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE (January 7, 2002)
  • K982134 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 (April 14, 1999)
  • K973291 — DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES (December 19, 1997)

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  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)