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510(k) K053410

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR by Kendall — Product Code FEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2006
Date Received
December 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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  • K061936 — KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 (August 9, 2006)
  • K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALIND (August 4, 2006)
  • K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (October 6, 2005)
  • K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (December 22, 2004)
  • K042461 — KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (December 10, 2004)
  • K042572 — KENDALL CO2NFIRM NOW CO2 DETECTOR (November 5, 2004)
  • K041914 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (September 27, 2004)
  • K041006 — TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR (May 19, 2004)

Other clearances for product code FEG

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  • K040388 — NEXT GENERATION SALEM SUMP (May 17, 2004)
  • K971354 — KNOTT NG TUBE (November 19, 1997)
  • K960176 — DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (July 24, 1996)
  • K926073 — ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (May 15, 1995)
  • K935781 — ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (January 27, 1995)
  • K921104 — LOPEZ VALVE WITH NG SUMP TUBE (October 26, 1992)
  • K900035 — WILSON-COOK COLON DECOMPRESSION SET (March 7, 1990)
  • K880850 — KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (May 26, 1988)