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510(k) K883610

LAKE FOLEY CATHETERIZATION TRAY by Lake Medical Products, Inc. — Product Code FCN

K883610 is an FDA 510(k) premarket notification submitted by Lake Medical Products, Inc. for the device "LAKE FOLEY CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Lake Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
August 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Drainage Collection Kit, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Lake Medical Products, Inc.

  • K943162 — LAKE STAGEZERO(TM) AIR FLOTATION BED (February 27, 1995)
  • K922730 — LAKE OSTOMY CARE SET (December 30, 1993)
  • K905053 — STAGE ZERO AIR FLOTATION BED (November 26, 1990)
  • K901835 — LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) (September 5, 1990)
  • K902508 — LAKE MALE EXTERNAL CATHETERIZATION KIT (August 23, 1990)
  • K902121 — LAKE GASTROSTOMY TUBE (July 27, 1990)
  • K884127 — LAKE N/G FEEDING TUBE (February 8, 1989)
  • K884128 — LAKE N/G EXTENSION SET (December 8, 1988)
  • K880578 — LAKE DISPOSABLE PROBE COVER (March 31, 1988)
  • K875383 — LAKE CATHETER CARE KITS (MODIFICATION) (March 9, 1988)

Other clearances for product code FCN

  • K951443 — STANDARD FOLEY SYSTEM PAK (June 15, 1995)
  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K915166 — MICROCYCLER (September 7, 1994)
  • K922346 — FEMALE URINE SAMPLING DEVICE (August 14, 1992)
  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)

FDA data resources