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510(k) K854365

IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS by Migada, Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1986
Date Received
October 29, 1985
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 Migada, Ltd.

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  • 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)

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