510(k) K853296

EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN by Parexel Intl. Corp. — Product Code BYY

K853296 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN". The FDA issued a decision of Substantially Equivalent on August 15, 1985. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.