510(k) K190327

ENConnect 40 mm Screw Cap to ENPlus Adapter by Cedic S.R.L. — Product Code PIF

K190327 is an FDA 510(k) premarket notification submitted by Cedic S.R.L. for the device "ENConnect 40 mm Screw Cap to ENPlus Adapter". The FDA issued a decision of Substantially Equivalent on April 9, 2019. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Cedic S.R.L. has at least 6 other 510(k) clearances on record.