Cleared Traditional

CYTOSMEAR BRUSH

K904160 · Brooke Intl. · Obstetrics & Gynecology

Nov 1990

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K904160 is an FDA 510(k) clearance for the CYTOSMEAR BRUSH, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Brooke Intl. (Pasadena, US). The FDA issued a Cleared decision on November 2, 1990, 52 days after receiving the submission on September 11, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number	K904160 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1990
Decision Date	November 02, 1990
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—