FDA 510(k) Application Details - K980212

Device Classification Name	Extractor, Vacuum, Fetal   More FDA Info for this Device
510(K) Number	K980212
Device Name	Extractor, Vacuum, Fetal
Applicant	PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN, ESQ. 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	01/21/1998
Decision Date	07/09/1998
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