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510(k) K771349

MODIFICATION TO KIDNEY DIALYZER by Erika, Inc. — Product Code FHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
July 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Single Coil
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)
  • K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (April 3, 1985)
  • K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (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)
  • K831173 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (June 22, 1984)

Other clearances for product code FHS

  • K812811 — MICROCOIL 80 DIALYZER (December 3, 1981)
  • K811974 — MICROCOIL 150 DIALYZER (September 16, 1981)
  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (December 17, 1980)
  • K800723 — MICRO-COIL 100 COIL DIALYZER (May 14, 1980)
  • K800174 — GAMBRO LUNDIA COIL DIALYZER (February 13, 1980)
  • K790223 — DIALYZER, CD-800 COIL (March 26, 1979)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (October 17, 1978)
  • K770735 — DIALYZER, COIL, CD, LSA, 5M1765 (May 10, 1977)
  • K761358 — COIL DIALYZER MODEL ALT 140 (January 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (November 19, 1976)