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510(k) K922730

LAKE OSTOMY CARE SET by Lake Medical Products, Inc. — Product Code EXB

K922730 is an FDA 510(k) premarket notification submitted by Lake Medical Products, Inc. for the device "LAKE OSTOMY CARE SET". The FDA issued a decision of Substantially Equivalent (kit) on December 30, 1993. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Lake Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 30, 1993
Date Received
June 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

Other clearances by Lake Medical Products, Inc.

  • K943162 — LAKE STAGEZERO(TM) AIR FLOTATION BED (February 27, 1995)
  • 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)
  • K875383 — LAKE CATHETER CARE KITS (MODIFICATION) (March 9, 1988)

Other clearances for product code EXB

  • K252140 — Heylo™ System (October 6, 2025)
  • K181643 — SmartBag (SmartPouch) (November 16, 2018)
  • K140938 — OSTOM-I ALERT (October 10, 2014)
  • K882878 — ODOR-END EMERGENCY CLEAN UP POWDER (December 8, 1988)
  • K881636 — CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (July 13, 1988)
  • K880306 — EMERGENCY-CLEAN UP(TM) ECP (May 20, 1988)
  • K872294 — COMBINATION NITE DRAINAGE UNIT (December 29, 1987)
  • K873929 — 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (December 3, 1987)
  • K871526 — ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (October 13, 1987)
  • K871738 — OSTO-PURE (August 12, 1987)

FDA data resources