FDA 510(k) Application Details - K960549

Device Classification Name	Extractor, Vacuum, Fetal   More FDA Info for this Device
510(K) Number	K960549
Device Name	Extractor, Vacuum, Fetal
Applicant	NEWARD ENTERPRISES, INC. P.O. BOX 725 CUCAMONGA, CA 91730 US Other 510(k) Applications for this Company
Contact	ALLYSON CARMACK 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	02/08/1996
Decision Date	08/29/1996
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