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510(k) K043033

GLOBAL TREASURES FLUID FILLED TEETHER by Global Treasure Industries , Ltd. — Product Code KKO

K043033 is an FDA 510(k) premarket notification submitted by Global Treasure Industries , Ltd. for the device "GLOBAL TREASURES FLUID FILLED TEETHER". The FDA issued a decision of Substantially Equivalent on March 22, 2005. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Global Treasure Industries , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2005
Date Received
November 3, 2004
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 by Global Treasure Industries , Ltd.

  • K062010 — RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES (October 27, 2006)
  • K030673 — FLEXIBLE TIP THERMOMETER, MODEL 011206 (April 4, 2003)
  • K030658 — STANDARD THERMOMETER (March 25, 2003)
  • K021052 — MODEL GT010706 ELECTRONIC THERMOMETER (April 9, 2002)

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)
  • K091198 — LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962 (December 7, 2009)
  • K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS (June 18, 2009)

FDA data resources