FDA · official record K811926Substantially Equivalent

SE WON(ALUMINUM) DENTAL FLOSS HOLDER

Name: SE WON(ALUMINUM) DENTAL FLOSS HOLDER — FDA K811926
Creator: Sewon Industry
Keywords: SE WON(ALUMINUM) DENTAL FLOSS HOLDER, SE WON(ALUMINUM) DENTAL FLOSS HOLDER, K811926, JES, FDA

United StatesJESSewon Industry

Verified

Official record identity

FDA application number: K811926
Decision date: July 28, 1981
Published decision: Substantially Equivalent

Classification

Product code: JES

Published parties

Applicant: Sewon Industry

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1981-07-06
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6390

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.