510(k) K883057

COMFORT CATH MALE EXTERNAL CATHETER by Sierra Laboratories, Inc. — Product Code EYT

K883057 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "COMFORT CATH MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on August 2, 1988. The device falls under product code EYT (Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Sierra Laboratories, Inc. has at least 10 other 510(k) clearances on record.