K181317

Substantially Equivalent

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Applicant: Wilson-Cook Medical, Inc.
Product code: FDX
Advisory panel: Gastroenterology, Urology
Date received: 2018-05-18
Decision date: 2019-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.