FDA 510(k) Application Details - K123151

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K123151
Device Name	Hysteroscope (And Accessories)
Applicant	ENDOSEE CORP 4546 EL CAMINO REAL, SUITE 215 LOS ALTOS, CA 94022 US Other 510(k) Applications for this Company
Contact	XIAOLONG(BRUCE) OUYANG Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2012
Decision Date	03/08/2013
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	Y
Expedited Review