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510(k) K941684

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE by Abbott Laboratories — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1994
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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