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510(k) K904223

SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS by Baxter Healthcare Corp — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
September 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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