510(k) K020628

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 by Bioteque America, Inc. — Product Code HHK

K020628 is an FDA 510(k) premarket notification submitted by Bioteque America, Inc. for the device "CURELLE, PREFERRED CURELLE, CUTEQ 2.5". The FDA issued a decision of Substantially Equivalent on May 24, 2002. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Bioteque America, Inc. has at least 9 other 510(k) clearances on record.