510(k) K951835

MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE by Life Technologies, Inc. — Product Code MFD

K951835 is an FDA 510(k) premarket notification submitted by Life Technologies, Inc. for the device "MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Life Technologies, Inc. has at least 3 other 510(k) clearances on record.