FDA · official record K950309Substantially Equivalent

EAGLE

Name: EAGLE — FDA K950309
Creator: Aalba Dent, Inc.
Keywords: EAGLE, EAGLE, K950309, EJI, FDA

United StatesEJIAalba Dent, Inc.

Verified

Official record identity

FDA application number: K950309
Decision date: February 16, 1995
Published decision: Substantially Equivalent

Classification

Product code: EJI

Published parties

Applicant: Aalba Dent, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-01-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6770

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.