510(k) K040388

NEXT GENERATION SALEM SUMP by Kendall — Product Code FEG

K040388 is an FDA 510(k) premarket notification submitted by Kendall for the device "NEXT GENERATION SALEM SUMP". The FDA issued a decision of Substantially Equivalent on May 17, 2004. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Kendall has at least 10 other 510(k) clearances on record.