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510(k) K013807

MICROJET QUARK, MODEL U100 OR U40 by Cane S.R.L. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2001
Date Received
November 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

Other clearances by Cane S.R.L.

  • K091042 — CRONO S-PID 50 (May 12, 2009)
  • K052218 — CRONO FIVE AND CRONO PCA 50 (November 23, 2005)
  • K052217 — CRONO SUPER PID (September 13, 2005)
  • K052219 — CRONO GO. (September 13, 2005)
  • K042085 — CRONO F (September 17, 2004)
  • K041414 — CRONO AND CRONO, MODEL 30 (July 8, 2004)
  • K013840 — MICROJET CRONO PAR AND CRONO APO-GO (May 14, 2002)
  • K013822 — MICROJET CRONO PCA (May 8, 2002)
  • K013234 — MICROJET CRONO (April 26, 2002)

Other clearances for product code LZG

  • K240158 — Modular Medical MODD1 Insulin Delivery System (September 4, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K223372 — Omnipod GO Insulin Delivery Device (April 24, 2023)
  • K210714 — Extended Reservoir (April 6, 2022)
  • K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (August 13, 2021)
  • K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (October 21, 2019)
  • K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (January 8, 2019)
  • K180045 — Omnipod DASH Insulin Management System (June 1, 2018)
  • K162296 — OmniPod Insulin Management System (April 18, 2017)
  • K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up (October 25, 2016)