FDA · official record K090793Substantially Equivalent

BONGROS HA

Name: BONGROS HA — FDA K090793
Creator: Bioalpha, Inc.
Keywords: BONGROS HA, BONGROS HA, K090793, LYC, FDA

United StatesLYCBioalpha, Inc.

Verified

Official record identity

FDA application number: K090793
Decision date: May 19, 2009
Published decision: Substantially Equivalent

Classification

Product code: LYC

Published parties

Applicant: Bioalpha, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-03-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

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.