FDA 510(k) Application Details - K963685

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K963685
Device Name	Spatula, Cervical, Cytological
Applicant	NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH TAICHUNG HSIEN 423 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	HHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/1996
Decision Date	10/11/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review