510(k) K915308

PEG GASTROSTOMY TUBE KIT by Sandoz Nutrition — Product Code FPD

K915308 is an FDA 510(k) premarket notification submitted by Sandoz Nutrition for the device "PEG GASTROSTOMY TUBE KIT". The FDA issued a decision of Substantially Equivalent - Kit on Mar 12, 1993. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Sandoz Nutrition has 19 other 510(k) clearances on record.