ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH

ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH is an FDA 510(k)-cleared medical device (K875162) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 1988. Regulation: 8.