510(k) K052105

WATER FILLED TEETHER by Royal Industries (Thailand) Public Co. , Ltd. — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2005
Date Received
August 3, 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