510(k) K082307

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT by Evenflo Company, Inc. — Product Code HGX

K082307 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT". The FDA issued a decision of Substantially Equivalent on September 11, 2008. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Evenflo Company, Inc. has at least 7 other 510(k) clearances on record.