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510(k) K141384

WHISPERJECT AUTOINJECTOR by Scandinavian Health Limited — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2014
Date Received
May 27, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Scandinavian Health Limited

  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K120191 — PUSH-ON NEEDLE 30GX8MM (May 23, 2012)

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)
  • 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)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)