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510(k) K083512

FLUID-FILLED TEETHER by Wiltec Industries , Ltd. — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2009
Date Received
November 26, 2008
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 Wiltec Industries , Ltd.

  • K961879 — ELECTRONIC THERMOMETER (June 10, 1996)

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  • K093370 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (January 21, 2010)
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  • 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)