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510(k) K030050

TORAYSULFONE DIALYZER, BS-L SERIES by Toray Industries (America), Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2003
Date Received
January 6, 2003
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 Toray Industries (America), Inc.

  • K042370 — TORAYGUIDE GUIDEWIRE (December 17, 2004)
  • K002512 — TORAYSULFONE DIALYZER (October 15, 2001)
  • K994198 — HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (August 25, 2000)
  • K942681 — FILTRYZER (June 22, 1995)
  • K935471 — FILTRYZER(TM) (May 19, 1995)
  • K940910 — FILTRYZER (May 4, 1995)
  • K884339 — TORAY FILTRYZER DIALYZERS (March 17, 1989)
  • K883407 — TORAY FILTRYZER BK SERIES (February 27, 1989)
  • K884083 — TORAY VASCULAR PROSTHESIS (January 12, 1989)
  • K882158 — MODIFIED TORAY FILTRYZER DIALYZERS (August 12, 1988)

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