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510(k) K853134

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 by Erika, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1985
Date Received
July 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Erika, Inc.

  • 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)
  • K842436 — ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (July 13, 1984)
  • 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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