510(k) K941542

ORION CENTRAL LINE DRESSING CHANGE TRAY by Regulatory & Marketing Services, Inc. — Product Code FRG

K941542 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "ORION CENTRAL LINE DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (kit) on May 23, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.