FDA · official record K034024Substantially Equivalent

TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS

Name: TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS — FDA K034024
Creator: Bisco, Inc.
Keywords: TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS, TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS, K034024, EBI, FDA

United StatesEBIBisco, Inc.

Verified

Official record identity

FDA application number: K034024
Decision date: March 19, 2004
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Bisco, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-12-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3760

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.