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510(k) K854391

HEMODIALYSIS CONCENTRATE by Dana Laboratories — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
October 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dana Laboratories

  • K851431 — HEMODIALYSIS CONCENTRATE ADDITIVES (June 12, 1985)

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  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)