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510(k) K112511

DOBBHOFF DUAL PORT FEEDING TUBE by Covidien Lp, Formerly Registered AS Kendall — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2012
Date Received
August 30, 2011
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 Covidien Lp, Formerly Registered AS Kendall

  • K130725 — MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (April 17, 2013)
  • K092205 — PALINDROME P HEMODIALYSIS CATHETER (October 30, 2009)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)