FDA · official record K983374Substantially Equivalent

AGATHA-A-H2010

Name: AGATHA-A-H2010 — FDA K983374
Creator: Midian Intl.
Keywords: AGATHA-A-H2010, AGATHA-A-H2010, K983374, EFS, FDA

United StatesEFSMidian Intl.

Verified

Official record identity

FDA application number: K983374
Decision date: December 23, 1998
Published decision: Substantially Equivalent

Classification

Product code: EFS

Published parties

Applicant: Midian Intl.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-09-25
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6510

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.