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510(k) K061103

HAEMONETICS 40U RBC FILTER BAG by Haemonetics Corp. — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2006
Date Received
April 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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