Home / 510(k) Clearances / K091198

510(k) K091198

LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING by Allied Hill Enterprises, Ltd. — Product Code KKO

K091198 is an FDA 510(k) premarket notification submitted by Allied Hill Enterprises, Ltd. for the device "LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING". The FDA issued a decision of Substantially Equivalent on December 7, 2009. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2009
Date Received
April 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Teething, Fluid-Filled
Device Class
Class II
Regulation Number
872.5550
Review Panel
DE
Submission Type

Other clearances for product code KKO

  • K123855 — WATER-FILLED TEETHER (May 24, 2013)
  • K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE (December 2, 2011)
  • K092025 — FLUID FILLED TEETHER - GEL (January 27, 2011)
  • K093266 — MAM COOLER (July 27, 2010)
  • K092781 — MAM TWISTER (June 23, 2010)
  • K092494 — GEL FILLED GUM SOOTHER (March 1, 2010)
  • K093370 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (January 21, 2010)
  • K092910 — FLUID-FILLED TEETHER (December 18, 2009)
  • K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS (June 18, 2009)
  • K082824 — FLUID FILLED TEETHER (May 27, 2009)

FDA data resources