510(k) K894925

AMCATH URETERAL DILATORS MODELS 7100,7110,7120 by Intec Medical, Inc. — Product Code EZN

K894925 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "AMCATH URETERAL DILATORS MODELS 7100,7110,7120". The FDA issued a decision of Substantially Equivalent on December 13, 1989. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.