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510(k) K073257

KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR by Kawasumi Laboratories, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2008
Date Received
November 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Kawasumi Laboratories, Inc.

  • K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (July 8, 2019)
  • K190233 — K-Shield Advantage Port Access Infusion Set (PAIS) (May 2, 2019)
  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (March 7, 2013)
  • K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (November 18, 2010)
  • K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR (November 3, 2010)
  • K061197 — KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER (June 30, 2006)
  • K060580 — K-SHIELD PORT ACCESS INFUSION SET (June 6, 2006)
  • K023917 — WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR (February 26, 2003)
  • K022110 — KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSI (September 12, 2002)

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