FDA · official record K881233Substantially Equivalent

STRAIGHT LENGTH ARCH WIRES

Name: STRAIGHT LENGTH ARCH WIRES — FDA K881233
Creator: Flexmedics
Keywords: STRAIGHT LENGTH ARCH WIRES, STRAIGHT LENGTH ARCH WIRES, K881233, EJF, FDA

United StatesEJFFlexmedics

Verified

Official record identity

FDA application number: K881233
Decision date: April 12, 1988
Published decision: Substantially Equivalent

Classification

Product code: EJF

Published parties

Applicant: Flexmedics

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1988-03-22
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5410

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.