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510(k) K873961

INFUMED 300 AMBULATORY INFUSION PUMP by Med Fusion Systems, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
September 29, 1987
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

Other clearances by Med Fusion Systems, Inc.

  • K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR (May 6, 1987)
  • K870907 — INTRODUCER, PERCUTANEOUS (April 9, 1987)
  • K864407 — REFILLABLE SYRINGE (January 20, 1987)
  • K863814 — BAG SPIKE EXTENSION SET (October 14, 1986)
  • K860616 — VOLUME CONTROL SET WITH EXTENSION (June 2, 1986)
  • K860803 — IV FILTER EXTENSION SET (April 9, 1986)
  • K844313 — INFUSET W/HUBER NEEDLE (January 22, 1985)
  • K842984 — EXTENSION SET W/INJECTION SITE (October 16, 1984)
  • K842143 — BENT WINGED MINI-VOL INFUSION SET (July 20, 1984)
  • K841882 — THREE WAY INFUSION SET (June 5, 1984)

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