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510(k) K935781

ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY by Sherwood Medical Co. — Product Code FEG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 27, 1995
Date Received
December 6, 1993
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

Other clearances by Sherwood Medical Co.

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  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. A (December 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (December 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K960677 — KANGAROO JEJUNAL FEEDING SYSTEM (May 13, 1996)
  • K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET (May 9, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (March 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (January 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (December 15, 1995)

Other clearances for product code FEG

  • K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set (August 1, 2017)
  • 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)
  • 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)