FDA · official record K844291Substantially Equivalent

ARK TONGUE CLEANER

Name: ARK TONGUE CLEANER — FDA K844291
Creator: Arkay Co.
Keywords: ARK TONGUE CLEANER, ARK TONGUE CLEANER, K844291, LCN, FDA

United StatesLCNArkay Co.

Verified

Official record identity

FDA application number: K844291
Decision date: November 23, 1984
Published decision: Substantially Equivalent

Classification

Product code: LCN

Published parties

Applicant: Arkay Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1984-11-05
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6855

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.