510(k) K991248

PRONTO DRY by Medical Instruments Corporation Mic AG — Product Code LYR

K991248 is an FDA 510(k) premarket notification submitted by Medical Instruments Corporation Mic AG for the device "PRONTO DRY". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Medical Instruments Corporation Mic AG has at least 1 other 510(k) clearance on record.