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510(k) K110615

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE by Bebe Toys Manufactory , Ltd. — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2011
Date Received
March 3, 2011
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

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  • 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)