510(k) K050887

GONGDONG DISPOSABLE VAGINAL SPECULUM by Zhejiang Gongdong Medical Plastic Factory — Product Code HIB

K050887 is an FDA 510(k) premarket notification submitted by Zhejiang Gongdong Medical Plastic Factory for the device "GONGDONG DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on July 11, 2005. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Zhejiang Gongdong Medical Plastic Factory has at least 1 other 510(k) clearance on record.