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510(k) K102890

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) by Kawasumi Laboratories America, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2010
Date Received
September 30, 2010
Clearance Type
Special
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.

  • K030385 — IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACC (April 15, 2003)
  • 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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