510(k) K014036

MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. by Medtrade Products , Ltd. — Product Code MDA

K014036 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.". The FDA issued a decision of Substantially Equivalent on February 14, 2002. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.