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510(k) K041495

PENTADEFLUE IV SOLUTION ADMINISTRATION SETS by Pentaferte S.P.A — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
June 4, 2004
Clearance Type
Abbreviated
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

Other clearances by Pentaferte S.P.A

  • K041496 — PENTATRASFU BLOOD TRANSFUSION SETS (June 30, 2005)
  • K002381 — PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES (January 11, 2001)

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