510(k) K942753

ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER by Researched, Novel Medical Devices (Rn/Md) — Product Code EYZ

K942753 is an FDA 510(k) premarket notification submitted by Researched, Novel Medical Devices (Rn/Md) for the device "ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER". The FDA issued a decision of Substantially Equivalent on November 2, 1994. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Researched, Novel Medical Devices (Rn/Md) has at least 2 other 510(k) clearances on record.