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510(k) K171619

14Fr Colon Decompression Set, Macon Colon Decompression Set by Cook Ireland, Ltd. — Product Code FEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2017
Date Received
June 2, 2017
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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Other clearances for product code FEG

  • K132314 — MEDLINE ANTI-REFLUX VALVE (September 18, 2013)
  • K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (January 6, 2006)
  • 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)