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510(k) K092494

GEL FILLED GUM SOOTHER by Luv N' Care, Ltd. — Product Code KKO

K092494 is an FDA 510(k) premarket notification submitted by Luv N' Care, Ltd. for the device "GEL FILLED GUM SOOTHER". The FDA issued a decision of Substantially Equivalent on March 1, 2010. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Luv N' Care, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2010
Date Received
August 14, 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 by Luv N' Care, Ltd.

  • K100385 — NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP (March 24, 2010)

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)
  • 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