FDA · official record K950511Substantially Equivalent

BLL-FIL 6140 PARTICLES

Name: BLL-FIL 6140 PARTICLES — FDA K950511
Creator: Bio-Interfaces, Inc.
Keywords: BLL-FIL 6140 PARTICLES, BLL-FIL 6140 PARTICLES, K950511, LYC, FDA

United StatesLYCBio-Interfaces, Inc.

Verified

Official record identity

FDA application number: K950511
Decision date: April 27, 1995
Published decision: Substantially Equivalent

Classification

Product code: LYC

Published parties

Applicant: Bio-Interfaces, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-02-06
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.