FDA 510(k) Application Details - K063367

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K063367
Device Name	Insufflator, Laparoscopic
Applicant	W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	SUSANNE RAAB 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	11/07/2006
Decision Date	05/23/2007
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