FDA · official record K022430Substantially Equivalent

ISO FUNCTIONAL

Name: ISO FUNCTIONAL — FDA K022430
Creator: GC America, Inc.
Keywords: ISO FUNCTIONAL, ISO FUNCTIONAL, K022430, ELW, FDA

United StatesELWGC America, Inc.

Verified

Official record identity

FDA application number: K022430
Decision date: October 18, 2002
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: GC America, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-07-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3660

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.