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510(k) K970653

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) by Baxter Healthcare Corp — Product Code MSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
February 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, High Flux
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

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Other clearances for product code MSF

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  • K970681 — ALTRA NOVA 200 HEMODIALYZER (July 23, 1998)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (March 11, 1998)
  • K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (January 11, 1998)
  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)