FDA · official record K110615Substantially Equivalent

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

Name: WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE — FDA K110615
Creator: Bebe Toys Manufactory , Ltd.
Keywords: WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE, WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE, K110615, KKO, FDA

United StatesKKOBebe Toys Manufactory , Ltd.

Verified

Official record identity

FDA application number: K110615
Decision date: December 02, 2011
Published decision: Substantially Equivalent

Classification

Product code: KKO

Published parties

Applicant: Bebe Toys Manufactory , Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-03-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5550

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.