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510(k) K892334

LEONARD TUBE by Surgidyne, Inc. — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1989
Date Received
April 5, 1989
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 Surgidyne, Inc.

  • K883582 — VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM (October 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K860030 — SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID (February 12, 1986)
  • K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. (July 1, 1985)
  • K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS (June 28, 1985)

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)
  • 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)