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510(k) K042129

F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK by Cedic S.R.L. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2005
Date Received
August 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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