FDA · official record K884515Substantially Equivalent

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED

Name: BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED — FDA K884515
Creator: Gatewood and Associates, Ltd.
Keywords: BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED, BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED, K884515, EKJ, FDA

United StatesEKJGatewood and Associates, Ltd.

Verified

Official record identity

FDA application number: K884515
Decision date: January 10, 1989
Published decision: Substantially Equivalent

Classification

Product code: EKJ

Published parties

Applicant: Gatewood and Associates, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1988-10-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4565

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.