FDA 510(k) Application Details - K080365

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K080365
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	NOUVAG AG REUSSWEHRSTRASSE 1 GEBENSTORF CH-5412 CH Other 510(k) Applications for this Company
Contact	ERICH FORSTER Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2008
Decision Date	06/29/2009
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