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510(k) K930781

INFUSION PUMP by Y — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
February 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K953225 — IVAC BALL VALCE ADMIN. SETS (September 27, 1995)
  • K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS (August 10, 1994)
  • K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET (June 22, 1994)
  • K931550 — EZ ADMINISTRATION SET (January 10, 1994)
  • K932544 — IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 (October 12, 1993)
  • K922115 — IVAC NEEDLELESS INJECTION VALVE (October 12, 1993)
  • K931549 — MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP (October 12, 1993)
  • K925228 — IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL (July 30, 1993)

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