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510(k) K842436

ERIKA NEGATIVE PRESS. ARTERIAL BLOOD by Erika, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1984
Date Received
June 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Erika, Inc.

  • K853134 — NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 (November 6, 1985)
  • K852310 — NATURALYTE BICARBONATE CONCENTRATE-DRY PACK (July 26, 1985)
  • K852309 — ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 (July 26, 1985)
  • K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (April 3, 1985)
  • K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (April 3, 1985)
  • K850654 — TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (March 7, 1985)
  • K850655 — TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (March 7, 1985)
  • K831174 — FILTRYZER HOLLOW FIBER ARTIFICIAL KID- (June 22, 1984)
  • K831176 — FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (June 22, 1984)
  • K831173 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (June 22, 1984)

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