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510(k) K963933

PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER by Baxter Healthcare Corp — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1997
Date Received
October 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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