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510(k) K030385

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR by Kawasumi Laboratories America, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2003
Date Received
February 5, 2003
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

Other clearances by Kawasumi Laboratories America, Inc.

  • K102890 — K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTEC (October 21, 2010)
  • K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY (July 21, 2000)
  • K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER (July 21, 2000)
  • K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD (July 21, 2000)
  • K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT (May 19, 2000)

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