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510(k) K851431

HEMODIALYSIS CONCENTRATE ADDITIVES by Dana Laboratories — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1985
Date Received
April 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Dana Laboratories

  • K854391 — HEMODIALYSIS CONCENTRATE (January 8, 1986)

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