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510(k) K943095

IV TRANSFER SPIKE by Migada, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
June 28, 1994
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 Migada, Ltd.

  • K954883 — FREE FLOW SAFETY DEVICE (April 23, 1996)
  • K933929 — LAB-SITE(R) SAFETY CANNULA (December 7, 1993)
  • K902881 — LAB-SITE SAFETY NEEDLE (September 26, 1990)
  • K870016 — ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (May 28, 1987)
  • K864453 — EMERGENCY & MILITARY INFUSION SYSTEM (January 20, 1987)
  • K863304 — PRESELECTED FLOW RATE I.V. SET (December 9, 1986)
  • K860952 — I.V. SET WITH AND WITHOUT AIR VENT (August 27, 1986)
  • K861275 — HIGH FLOW I.V. SET (June 2, 1986)
  • K860595 — TRANSFER SET (April 7, 1986)
  • K854365 — IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS (March 24, 1986)

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