FDA · official record K063837Substantially Equivalent

SIGMA M

Name: SIGMA M — FDA K063837
Creator: Instrumentarium Dental, Palodex Group OY
Keywords: SIGMA M, SIGMA M, K063837, MUH, FDA

United StatesMUHInstrumentarium Dental, Palodex Group OY

Verified

Official record identity

FDA application number: K063837
Decision date: July 02, 2007
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: Instrumentarium Dental, Palodex Group OY

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-12-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.