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510(k) K822928

DISPOSABLE MICRO-INFUSION SYSTEM by Orange Medical Instruments, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
October 4, 1982
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 Orange Medical Instruments, Inc.

  • K860808 — CONTINUCATH (March 13, 1986)
  • K851822 — BETA SCAN TRENDS METER (October 3, 1985)
  • K844796 — MICRO-BETA U100 SYRINGE (December 18, 1984)
  • K843882 — TRENDS LANCET (November 5, 1984)
  • K841369 — BETA SCAN DRYSTIX (August 23, 1984)
  • K833705 — BETAJECT BD U100 (May 9, 1984)
  • K833706 — CLICK-COUNT U100 INSULIN SYRINGE (April 5, 1984)
  • K832691 — BETA SCAN REAGENT STRIP (November 14, 1983)
  • K832793 — NEOCATH 1000 W/HEPCOTE (September 26, 1983)
  • K831897 — BETA I PROGRAMMABLE INFUSION PUMP (August 12, 1983)

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