510(k) K032840

ATRION MEDICAL QL INFLATION DEVICE by Atrion Medical Products, Inc. — Product Code KOE

K032840 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL QL INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on March 3, 2004. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.