510(k) K092025

FLUID FILLED TEETHER - GEL by Kids II — Product Code KKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2011
Date Received
July 6, 2009
Clearance Type
Abbreviated
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