FDA 510(k) Application Details - K955393

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K955393
Device Name	Insufflator, Laparoscopic
Applicant	SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN. DACULA, GA 30211-3007 US Other 510(k) Applications for this Company
Contact	MICHAEL A CLARK 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	11/24/1995
Decision Date	01/09/1997
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