FDA · official record K101902Substantially Equivalent

J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030

Name: J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 — FDA K101902
Creator: Jeil Medical Corporation
Keywords: J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030, J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030, K101902, DZL, FDA

United StatesDZLJeil Medical Corporation

Verified

Official record identity

FDA application number: K101902
Decision date: February 08, 2011
Published decision: Substantially Equivalent

Classification

Product code: DZL

Published parties

Applicant: Jeil Medical Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-07-08
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4880

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.