510(k) K954097

SELECTCELLS STANDARD by Select Medical Systems, Inc. — Product Code HHK

K954097 is an FDA 510(k) premarket notification submitted by Select Medical Systems, Inc. for the device "SELECTCELLS STANDARD". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Select Medical Systems, Inc. has at least 5 other 510(k) clearances on record.