FDA 510(k) Application Details - K011532

Device Classification Name	Extractor, Vacuum, Fetal   More FDA Info for this Device
510(K) Number	K011532
Device Name	Extractor, Vacuum, Fetal
Applicant	PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. WASHINGTON, DC 20004-5600 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN 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	05/18/2001
Decision Date	07/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review