510(k) K954429

KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT by Sherwood Medical Co. — Product Code KNT

K954429 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT". The FDA issued a decision of Substantially Equivalent (kit) on March 8, 1996. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.