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510(k) K864407

REFILLABLE SYRINGE by Med Fusion Systems, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
November 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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)
  • 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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