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510(k) K842984

EXTENSION SET W/INJECTION SITE by Med Fusion Systems, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1984
Date Received
July 30, 1984
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 Med Fusion Systems, Inc.

  • K873961 — INFUMED 300 AMBULATORY INFUSION PUMP (December 29, 1987)
  • 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)
  • K842143 — BENT WINGED MINI-VOL INFUSION SET (July 20, 1984)
  • K841882 — THREE WAY INFUSION SET (June 5, 1984)

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