510(k) K911349

E-Z-EM ENTEROCLYSIS CATHETER SET by E-Z-Em, Inc. — Product Code EZK

K911349 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-EM ENTEROCLYSIS CATHETER SET". The FDA issued a decision of Substantially Equivalent on November 16, 1992. The device falls under product code EZK (Catheter, Retention Type), a Class II device regulated under 21 CFR 876.5980. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.