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510(k) K820004

PLEUROFIX THORACENTESIS KIT by Burron Medical Products, Inc. — Product Code GAZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)