FDA · official record K925116Substantially Equivalent

ELECTROSURGICAL ELECTRODE

Name: ELECTROSURGICAL ELECTRODE — FDA K925116
Creator: Premier
Keywords: ELECTROSURGICAL ELECTRODE, ELECTROSURGICAL ELECTRODE, K925116, EKZ, FDA

United StatesEKZPremier

Verified

Official record identity

FDA application number: K925116
Decision date: March 01, 1994
Published decision: Substantially Equivalent

Classification

Product code: EKZ

Published parties

Applicant: Premier

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1992-10-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4920

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.