CYTOSMEAR BRUSH— 510(k) K904160

Substantially Equivalent

Brooke Intl.

FDA 510(k) clearance K904160 for CYTOSMEAR BRUSH, Substantially Equivalent on 1990-11-02. Applicant: Brooke Intl.. Device class: 2.

Clearance details

Applicant: Brooke Intl.
Product code: Code HHI
Device class: Class 2
Regulation: 21 CFR 884.5070
Advisory panel: Obstetrics/Gynecology
Date received: 1990-09-11
Decision date: 1990-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, 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.