FDA 510(k) Application Details - K050887

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K050887
Device Name	Speculum, Vaginal, Nonmetal
Applicant	ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY BEICHENG INDUSTRIAL AREA HUANGYAN 318020 CN Other 510(k) Applications for this Company
Contact	WEIFENG ZHONG Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2005
Decision Date	07/11/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review