510(k) K880201

REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600 by Superior Healthcare Group, Inc. — Product Code KNT

K880201 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.