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510(k) K000263

GO MEDICAL BALLOON INFUSION SYSTEM by Go Medical Industries Pty. , Ltd. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2000
Date Received
January 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Go Medical Industries Pty. , Ltd.

  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT (December 27, 2000)
  • K910007 — SPRINGFUSOR 10R (November 2, 1993)
  • K900336 — V SET (October 4, 1990)
  • K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (October 6, 1989)
  • K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI) (September 12, 1989)
  • K891465 — OBSTETRIC CUP (MODIFICATION) (May 11, 1989)
  • K885283 — ASPIRATING AND IRRIGATING CYSTS NEEDLES (March 22, 1989)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)
  • K840008 — O'NEIL OBSTETRIC CUP (April 25, 1984)

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  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)