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 Dec 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
Dec 7, 2009
Date Received
Apr 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
510(k) Exempt

Other clearances for product code KKO

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

FDA data resources

Source: FDA 510(k) database entry for K091198. Report a data issue: hello@regdatalab.com.