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510(k) K833705

BETAJECT BD U100 by Orange Medical Instruments, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
October 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
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)
  • 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)
  • K831523 — BETA SCAN NORMAL CONTROL SOLUTION (July 19, 1983)

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