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510(k) K884978

PHARMA-PLAST INSULIN INFUSION SET by Pharma-Plast USA, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1989
Date Received
November 30, 1988
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 Pharma-Plast USA, Inc.

  • K894371 — NIPRO SAFELET CATH (October 25, 1989)
  • K894373 — NIPRO DENTAL NEEDLE (October 13, 1989)
  • K894374 — BLOOD DRAWING NEEDLE (September 28, 1989)
  • K894372 — NIPRO NEEDLE HOLDER (September 28, 1989)
  • K871263 — MULTIPLE PHARMA-PLAST TRACHEAL TUBE (June 15, 1987)
  • K852443 — PHARMA-PLAST CLINIPAK (October 16, 1985)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)
  • K852442 — PHARMA-PLAST NEEDLE (September 20, 1985)

Other clearances for product code LZG

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  • 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)