FDA 510(k) Application Details - K950035

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K950035
Device Name	Insufflator, Laparoscopic
Applicant	W.O.M. GMBH PASCALSTRABE 11 BERLIN D-10587 DE Other 510(k) Applications for this Company
Contact	OWEN B LAMB 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	01/04/1995
Decision Date	02/12/1996
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