FDA · official record K931353Substantially Equivalent

FLOSS PLUS

Name: FLOSS PLUS — FDA K931353
Creator: Floss Plus, Inc.
Keywords: FLOSS PLUS, FLOSS PLUS, K931353, JES, FDA

United StatesJESFloss Plus, Inc.

Verified

Official record identity

FDA application number: K931353
Decision date: July 27, 1993
Published decision: Substantially Equivalent

Classification

Product code: JES

Published parties

Applicant: Floss Plus, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-03-17
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.