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510(k) K945660

AUTOJECT 2 by Owen Mumford USA, Inc. — Product Code KZH

K945660 is an FDA 510(k) premarket notification submitted by Owen Mumford USA, Inc. for the device "AUTOJECT 2". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Owen Mumford USA, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
November 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

Other clearances by Owen Mumford USA, Inc.

  • K013362 — AUTOJECT 2 (November 13, 2001)
  • K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE) (November 10, 1999)
  • K983994 — UNIFINE (January 8, 1999)
  • K983974 — OWEN MUMFORD 3ML AUTOPEN (December 21, 1998)
  • K982275 — RAPPORT V.T.D. (December 4, 1998)
  • K983045 — AMIELLE (November 25, 1998)
  • K973899 — UNIFINE PENTIPS (December 4, 1997)
  • K971443 — RAPPORT V.T.D. (September 26, 1997)
  • K953735 — AUTOJECT MINI (November 8, 1995)

Other clearances for product code KZH

  • K243232 — GripMate (December 2, 2024)
  • K213429 — AccuSert Needle Inserter (October 20, 2022)
  • K163400 — Orbit Inserter (July 26, 2017)
  • K160860 — MiniMed Quick-serter (September 22, 2016)
  • K141384 — WHISPERJECT AUTOINJECTOR (September 12, 2014)
  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2) (October 2, 2008)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)

FDA data resources