FDA · official record K001260Substantially Equivalent

ALLROUND 55 LF

Name: ALLROUND 55 LF — FDA K001260
Creator: J.F. Jelenko & Co., Inc.
Keywords: ALLROUND 55 LF, ALLROUND 55 LF, K001260, EJT, FDA

United StatesEJTJ.F. Jelenko & Co., Inc.

Verified

Official record identity

FDA application number: K001260
Decision date: May 17, 2000
Published decision: Substantially Equivalent

Classification

Product code: EJT

Published parties

Applicant: J.F. Jelenko & Co., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-04-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3060

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.