510(k) K031094

FLUID FILLED TEETHERS by Royal King Infant Products Co. , Ltd. — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2003
Date Received
April 7, 2003
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