FDA 510(k) Application Details - K021193

Device Classification Name	Extractor, Vacuum, Fetal   More FDA Info for this Device
510(K) Number	K021193
Device Name	Extractor, Vacuum, Fetal
Applicant	FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG TAIPEI HSIEN 252 TW Other 510(k) Applications for this Company
Contact	TAIPEI HSIEN Other 510(k) Applications for this Contact
Regulation Number	884.4340   More FDA Info for this Regulation Number
Classification Product Code	HDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2002
Decision Date	02/12/2003
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