510(k) K962611

BARD EAGLE INFLATION DEVICE by Ryder Intl. Corp. — Product Code KOE

K962611 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "BARD EAGLE INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on October 21, 1996. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Ryder Intl. Corp. has at least 9 other 510(k) clearances on record.