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510(k) K875383

LAKE CATHETER CARE KITS (MODIFICATION) by Lake Medical Products, Inc. — Product Code KOD

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
March 9, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
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)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K880578 — LAKE DISPOSABLE PROBE COVER (March 31, 1988)

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