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510(k) K905573

XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A by Zeon Medical Corp. — Product Code BSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1991
Date Received
December 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Zeon Medical Corp.

  • K913521 — XEMEX TEMPORARY PACING CATHETER A MODIFIED (December 27, 1991)
  • K904868 — XEMEX TEMPORARY PACING CATHETER A (May 16, 1991)

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  • K961711 — ASPISAFE GASTRIC TUBE (June 11, 1997)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)
  • K935688 — AN-10S ANDERSEN TUBE WITH STYLET (December 30, 1994)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBE (April 19, 1991)
  • K894870 — WILTEK NASAL BILIARY DRAINAGE SET (December 21, 1989)