FDA · official record K841327Substantially Equivalent

DENTAL COTTON ROLLS

Name: DENTAL COTTON ROLLS — FDA K841327
Creator: Intl. Verbandstoff-Fabrik Schaffhau
Keywords: DENTAL COTTON ROLLS, DENTAL COTTON ROLLS, K841327, EFN, FDA

United StatesEFNIntl. Verbandstoff-Fabrik Schaffhau

Verified

Official record identity

FDA application number: K841327
Decision date: July 03, 1984
Published decision: Substantially Equivalent

Classification

Product code: EFN

Published parties

Applicant: Intl. Verbandstoff-Fabrik Schaffhau

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1984-04-02
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6050

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.