510(k) K052531

FU HONG INDUSTRIES LIMITED SOOTHER TEETHER by Fu Hong Industries , Ltd. — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2005
Date Received
September 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