FDA · official record K092917Substantially Equivalent

STERN'S S250 NORDAM

Name: STERN'S S250 NORDAM — FDA K092917
Creator: Cefla S.C.
Keywords: STERN'S S250 NORDAM, STERN'S S250 NORDAM, K092917, EIA, FDA

United StatesEIACefla S.C.

Verified

Official record identity

FDA application number: K092917
Decision date: June 24, 2010
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Cefla S.C.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2009-09-22
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.