FDA · official record K092319Substantially Equivalent

STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387

Name: STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 — FDA K092319
Creator: Danville Materials, Inc.
Keywords: STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387, STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387, K092319, ELW, FDA

United StatesELWDanville Materials, Inc.

Verified

Official record identity

FDA application number: K092319
Decision date: September 16, 2009
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: Danville Materials, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-08-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3660

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.