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510(k) K903611

ILC LEG BAG HOLDER by Inman Liebelt Corp. — Product Code FAQ

K903611 is an FDA 510(k) premarket notification submitted by Inman Liebelt Corp. for the device "ILC LEG BAG HOLDER". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Inman Liebelt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
August 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Inman Liebelt Corp.

  • K912211 — INTRAVASCULAR CATHETER SECURMENT DEVICE (August 9, 1991)
  • K912146 — URETERAL CATHETER HOLDER (July 26, 1991)
  • K905590 — UCEZ - STERILE LENS FOG REDUCTION DEVICE (May 10, 1991)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903610 — O.R. TIP CLEANER (October 19, 1990)

Other clearances for product code FAQ

  • K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZ (July 18, 1996)
  • K960217 — CPR URINE BAG (March 28, 1996)
  • K955609 — CONVEEN URINE BAG - STERILE (December 29, 1995)
  • K953767 — PROSYS BEDSIDE DRAINAGE BAG (December 20, 1995)
  • K953783 — CONVEEN LEG BAG STRAP (September 13, 1995)
  • K951945 — PROSYS LEG BAG (May 25, 1995)
  • K945204 — URINE COLLECTOR & ACCESSORIES (November 2, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)

FDA data resources