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510(k) K981286

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS by Armm, Inc. — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1998
Date Received
April 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Armm, Inc.

  • K923201 — ENDOSI SUCTION IRRIGATOR (September 23, 1993)
  • K922245 — SUPER-FLOW TUBING (September 3, 1993)
  • K931607 — MEDDRAINS (August 6, 1993)

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)
  • K911788 — ECONOVAGE R (July 26, 1991)