FDA · official record K030425Substantially Equivalent

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

Name: LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER — FDA K030425
Creator: Walter Lorenz Surgical, Inc.
Keywords: LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER, LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER, K030425, JEY, FDA

United StatesJEYWalter Lorenz Surgical, Inc.

Verified

Official record identity

FDA application number: K030425
Decision date: May 14, 2004
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Walter Lorenz Surgical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-02-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4760

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.