510(k) K170368

Sterile NS System by Jeil Medical Corporation — Product Code GWO

K170368 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "Sterile NS System". The FDA issued a decision of Substantially Equivalent on September 11, 2017. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.