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510(k) K994323

KAWASUMI LABORATORIES PHILEBOTOMY SET by Kawasumi Laboratories Co., Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2000
Date Received
December 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Kawasumi Laboratories Co., Ltd.

  • K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (February 12, 1998)
  • K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (March 14, 1997)
  • K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER (February 10, 1994)
  • K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION (February 3, 1994)
  • K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER (February 3, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921901 — PORT ACCESS INFUSION SET (September 10, 1993)
  • K921902 — PORT ACCESS NEEDLE (July 28, 1993)
  • K923323 — INTERMITTENT INJECTION SITE (July 13, 1993)
  • K896895 — KAWASUMI I.V. ADMINISTRATION SET (September 12, 1990)

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