FDA 510(k) Application Details - K983326

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K983326
Device Name	Insufflator, Laparoscopic
Applicant	NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. ELGIN, IL 60123 US Other 510(k) Applications for this Company
Contact	CASSEY KUREK Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1998
Decision Date	02/05/1999
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