FDA 510(k) Application Details - K963377

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K963377
Device Name	Speculum, Vaginal, Nonmetal
Applicant	NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. TUNG-SHIH TAICHUNG HSIEN TW Other 510(k) Applications for this Company
Contact	SARA CHEN 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	08/27/1996
Decision Date	10/04/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review