HORIZONS CYTOLOGY BRUSH— 510(k) K021998

Substantially Equivalent

Horizons Intl. Corp.

FDA 510(k) clearance K021998 for HORIZONS CYTOLOGY BRUSH, Substantially Equivalent on 2002-07-12. Applicant: Horizons Intl. Corp.. Device class: 2.

Clearance details

Applicant: Horizons Intl. Corp.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2002-06-19
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ponce, PR, 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.