BERGER PROSTATE CULTURE CYTOLOGY BRUSH— 510(k) K880095

Name: FDA 510(k) clearance K880095
Creator: U.S. Food and Drug Administration
Published: 1988-03-02

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K880095 for BERGER PROSTATE CULTURE CYTOLOGY BRUSH, Substantially Equivalent on 1988-03-02. Applicant: Van-Tec, Inc.. Device class: 2.

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-12
Decision date: 1988-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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