FDA · official record K981202Substantially Equivalent

WATER FILLED GUM SOOTHER

Name: WATER FILLED GUM SOOTHER — FDA K981202
Creator: Corium Corp.
Keywords: WATER FILLED GUM SOOTHER, WATER FILLED GUM SOOTHER, K981202, KKO, FDA

United StatesKKOCorium Corp.

Verified

Official record identity

FDA application number: K981202
Decision date: June 16, 1998
Published decision: Substantially Equivalent

Classification

Product code: KKO

Published parties

Applicant: Corium Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-04-02
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.