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510(k) K131183

MED-RX ORAL/ENTERAL SYRINGE by Benlan, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2014
Date Received
April 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Benlan, Inc.

  • K120375 — MED-RX PATIENT DELIVERY SET (June 28, 2012)
  • K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR (December 23, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS (November 8, 2010)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K990777 — MED-RX EXTENSION SETS (August 25, 1999)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
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