510(k) K802989

MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. by Swiss American Metal Craft Corp. — Product Code EJL

K802989 is an FDA 510(k) premarket notification submitted by Swiss American Metal Craft Corp. for the device "MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Swiss American Metal Craft Corp. has at least 3 other 510(k) clearances on record.