FDA · official record K974369Substantially Equivalent

APOLLO 9500

Name: APOLLO 9500 — FDA K974369
Creator: Ion Laser Technology
Keywords: APOLLO 9500, APOLLO 9500, K974369, EBZ, FDA

United StatesEBZIon Laser Technology

Verified

Official record identity

FDA application number: K974369
Decision date: January 06, 1998
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Ion Laser Technology

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-11-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.