510(k) K080878

MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) by Medical Technologies of Georgia, Inc. — Product Code KOD

K080878 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia, Inc. for the device "MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)". The FDA issued a decision of Substantially Equivalent on July 17, 2008. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Medical Technologies of Georgia, Inc. has at least 10 other 510(k) clearances on record.