510(k) K982894

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT by Ballard Medical Products — Product Code KNT

K982894 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT". The FDA issued a decision of Substantially Equivalent on September 11, 1998. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Ballard Medical Products has at least 10 other 510(k) clearances on record.