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510(k) K902508

LAKE MALE EXTERNAL CATHETERIZATION KIT by Lake Medical Products, Inc. — Product Code FCM

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 23, 1990
Date Received
June 5, 1990
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 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)
  • 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)
  • K875383 — LAKE CATHETER CARE KITS (MODIFICATION) (March 9, 1988)

Other clearances for product code FCM

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  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
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  • 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)