FDA · official record K031681Substantially Equivalent

STERISIL ANTIMICROBIAL TUBING AND BOTTLE

Name: STERISIL ANTIMICROBIAL TUBING AND BOTTLE — FDA K031681
Creator: Sterisil
Keywords: STERISIL ANTIMICROBIAL TUBING AND BOTTLE, STERISIL ANTIMICROBIAL TUBING AND BOTTLE, K031681, EIA, FDA

United StatesEIASterisil

Verified

Official record identity

FDA application number: K031681
Decision date: October 30, 2003
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Sterisil

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-05-30
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.