FDA · official record K964271Substantially Equivalent

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID

Name: IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID — FDA K964271
Creator: Airel-West
Keywords: IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID, IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID, K964271, EIA, FDA

United StatesEIAAirel-West

Verified

Official record identity

FDA application number: K964271
Decision date: December 19, 1997
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Airel-West

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-10-25
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.