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510(k) K820575

J.E.T. DIALYSIS SYSTEM by Computer Dialysis Systems, Inc. — Product Code FKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1982
Date Received
March 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Computer Dialysis Systems, Inc.

  • K850127 — FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G (March 20, 1985)
  • K831132 — COMPUDIAL/KP-1 (August 8, 1983)
  • K813107 — COMPUDIAL/KP-1 (March 23, 1982)

Other clearances for product code FKJ

  • K901734 — SERIM RESIDUAL CHLORINE TEST KIT (September 13, 1990)
  • K841307 — BBL GASPAK POUCH (May 14, 1984)
  • K772040 — TRANSDUCER PROTECTOR (November 28, 1977)