510(k) K053410

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR by Kendall — Product Code FEG

K053410 is an FDA 510(k) premarket notification submitted by Kendall for the device "GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR". The FDA issued a decision of Substantially Equivalent on January 6, 2006. 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.