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510(k) K053493

BERRY FRUITY TEETHER by Evenflo Company, Inc. — Product Code KKO

K053493 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "BERRY FRUITY TEETHER". The FDA issued a decision of Substantially Equivalent on February 22, 2006. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Evenflo Company, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2006
Date Received
December 15, 2005
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 Evenflo Company, Inc.

  • K102600 — SIMPLYGO BREAST PUMP (December 22, 2010)
  • K100435 — AMEDA PLATINUM BREAST PUMP (May 28, 2010)
  • K092770 — SIMPLYGO HANDS FREE BREAST PUMP (October 9, 2009)
  • K082307 — EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT (September 11, 2008)
  • K052909 — EVENFLO ELAN BREAST PUMP (November 1, 2005)
  • K022933 — EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT (December 2, 2002)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)

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