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510(k) K971259

COMBIPORT FLUID LAVAGE DEVICE by B.Braun Medical, Inc. — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1997
Date Received
April 4, 1997
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)
  • 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)