510(k) K853295

EMODREN EXCHANGEABLE PLASTIC BELLOWS by Parexel Intl. Corp. — Product Code GCY

K853295 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "EMODREN EXCHANGEABLE PLASTIC BELLOWS". The FDA issued a decision of Substantially Equivalent on August 20, 1985. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.