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510(k) K884339

TORAY FILTRYZER DIALYZERS by Toray Industries (America), Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
October 14, 1988
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 Toray Industries (America), Inc.

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  • K030050 — TORAYSULFONE DIALYZER, BS-L SERIES (September 29, 2003)
  • 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)
  • 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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