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510(k) K970663

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) by Baxter Healthcare Corp — Product Code MSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 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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