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510(k) K092025

FLUID FILLED TEETHER - GEL by Kids II — Product Code KKO

K092025 is an FDA 510(k) premarket notification submitted by Kids II for the device "FLUID FILLED TEETHER - GEL". The FDA issued a decision of Substantially Equivalent on January 27, 2011. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Kids II has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2011
Date Received
July 6, 2009
Clearance Type
Abbreviated
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 Kids II

  • K082824 — FLUID FILLED TEETHER (May 27, 2009)

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)
  • 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)
  • K082824 — FLUID FILLED TEETHER (May 27, 2009)

FDA data resources