510(k) K944383

ORION RED URETHRAL CATHETER by Regulatory & Marketing Services, Inc. — Product Code EZD

K944383 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "ORION RED URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on December 6, 1994. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.