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510(k) K011537

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS by Dynamic Technology Corp. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2002
Date Received
May 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Dynamic Technology Corp.

  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)
  • 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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