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510(k) K910022

MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT by Medical Marketing Group — Product Code FCM

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 2, 1991
Date Received
January 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medical Marketing Group

  • K884819 — O'NEIL URINARY CATHETER INTRODUCER (February 17, 1989)
  • K874682 — MMG CATHETER PLUG W/DRAINAGE TUBE COVER (January 27, 1988)
  • K871999 — MMG URO-SELF CATHETER (August 25, 1987)
  • K863912 — THE MMG 5 IN 1 CONNECTOR (October 27, 1986)
  • K840838 — MMG CONNECTIVE TUBING (March 30, 1984)
  • K821168 — DISPOSABLE URINARY LEGBAG W/STRAP (May 24, 1982)
  • K811469 — MMG URINARY DRAINAGE TUBING (June 12, 1981)
  • K800694 — MMG DISPOSABLE URINARY LEG BAG (May 30, 1980)
  • K791847 — ASPRI-LUKE (October 2, 1979)
  • K790279 — CATHETER, MMG LATEX EXTERNAL (March 6, 1979)

Other clearances for product code FCM

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  • K223821 — Self-Cath Closed System (August 2, 2023)
  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)