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510(k) K050805

30 ML OR 60 ML PEDI-SYRINGE FILTER by Blood Products Specialties, LLC — Product Code BRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2005
Date Received
March 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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