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510(k) K954883

FREE FLOW SAFETY DEVICE by Migada, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
October 20, 1995
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, Inc.

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  • 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)
  • K860605 — FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER (March 24, 1986)

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