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510(k) K882714

URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 by Lsl Industries, Inc. — Product Code EYZ

K882714 is an FDA 510(k) premarket notification submitted by Lsl Industries, Inc. for the device "URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450". The FDA issued a decision of Substantially Equivalent on January 31, 1989. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Lsl Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1989
Date Received
July 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Lsl Industries, Inc.

  • K831762 — SITZ BATH, SINGLE PATIENT USE #8100 (June 24, 1983)

Other clearances for product code EYZ

  • K964219 — ZIP CONDOM CATHETER (August 11, 1997)
  • K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10 (November 19, 1996)
  • K952780 — URINARY GEL DRAINAGE SYSTEM (December 12, 1995)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAG (May 14, 1993)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)

FDA data resources