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510(k) K200051

PUGGLE Enteral Feeding Pump and Feeding Set by Amsino International, Inc. — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
January 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Amsino International, Inc.

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  • K220267 — AMSafe NeuFlo Needleless Connector (October 7, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)
  • K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe (July 12, 2019)
  • K181445 — AMSure Hydrophilic Intermittent Catheter (October 1, 2018)
  • K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (September 7, 2018)
  • K173665 — AMSafe Sure-Lok Needle-Free Connector (September 5, 2018)
  • K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (September 4, 2018)
  • K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip (March 30, 2018)
  • K101958 — AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (September 29, 2010)

Other clearances for product code LZH

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  • K221603 — Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (December 20, 2022)
  • K220230 — AMSure Enteral Feeding Pump (November 10, 2022)
  • K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangar (July 6, 2016)
  • K143263 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (May 29, 2015)
  • K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS (December 23, 2014)
  • K131154 — ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG E (February 12, 2014)
  • K111381 — MEDI-SIS SYRINGE INFUSION SYSTEM (January 13, 2012)
  • K060316 — COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (June 23, 2006)
  • K040957 — NOA III ENTERAL NUTRITION PUMP (May 21, 2004)