510(k) K083153

ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 by Hollister, Inc. — Product Code KNT

K083153 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007". The FDA issued a decision of Substantially Equivalent (kit) on February 4, 2009. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Hollister, Inc. has at least 10 other 510(k) clearances on record.