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510(k) K800174

GAMBRO LUNDIA COIL DIALYZER by Gambro, Inc. — Product Code FHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 25, 1980
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

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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)
  • K790223 — DIALYZER, CD-800 COIL (March 26, 1979)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (October 17, 1978)
  • K771349 — MODIFICATION TO KIDNEY DIALYZER (August 2, 1977)
  • 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)