510(k) K935643

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE by Regulatory & Marketing Services, Inc. — Product Code KNY

K935643 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.