510(k) K904299

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF by E-Z-Em, Inc. — Product Code FGD

K904299 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF". The FDA issued a decision of Substantially Equivalent on November 27, 1990. The device falls under product code FGD (Catheter, Retention, Barium Enema With Bag), a Class II device regulated under 21 CFR 876.5980. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.