510(k) K904248

MODEL GLASE 210 HOLMIUM LASER SYSTEM by Charles L. Rose and Co., Inc. — Product Code HGF

K904248 is an FDA 510(k) premarket notification submitted by Charles L. Rose and Co., Inc. for the device "MODEL GLASE 210 HOLMIUM LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 14, 1990. The device falls under product code HGF (Source, Abortion Unit, Vacuum), a Class II device regulated under 21 CFR 884.5070. Charles L. Rose and Co., Inc. has at least 3 other 510(k) clearances on record.