510(k) K063223

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS by CooperSurgical, Inc. — Product Code HDW

K063223 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS". The FDA issued a decision of Substantially Equivalent on January 23, 2008. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.