510(k) K082470

SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA by Inter-Med, Inc. — Product Code KJJ

K082470 is an FDA 510(k) premarket notification submitted by Inter-Med, Inc. for the device "SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA". The FDA issued a decision of Substantially Equivalent on April 3, 2009. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Inter-Med, Inc. has at least 10 other 510(k) clearances on record.