WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE


Device Classification Name

ring, teething, fluid-filled

510(k) Number K110615
Device Name WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
Applicant
BEBE TOYS MANUFACTORY LTD.
34 mcnamara street
stoughton, 
MA 
02072

Applicant Contact paul a ware
Correspondent
BEBE TOYS MANUFACTORY LTD.
34 mcnamara street
stoughton, 
MA 
02072

Correspodent Contact paul a ware
Regulation Number 872.5550
Classification Product Code
KKO  
Date Received 03/03/2011
Decision Date 12/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No