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510(k) K951533

EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT by Ballard Medical Products — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1995
Date Received
April 3, 1995
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

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Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (June 19, 1998)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • 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)