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510(k) K001685

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 by Baxter Healthcare Corp — Product Code MSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2000
Date Received
June 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, Low Flux
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code MSE

  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (August 27, 1998)
  • K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (November 12, 1997)
  • K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (November 12, 1997)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)