FDA 510(k) Application Details - K955791

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K955791
Device Name	Insufflator, Laparoscopic
Applicant	W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST WASHIGNTON, DC 20005-3306 US Other 510(k) Applications for this Company
Contact	ROBERT P REZNICK 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	12/22/1995
Decision Date	12/17/1996
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