FDA 510(k) Application Details - K110852

Device Classification Name	Insufflator, Hysteroscopic   More FDA Info for this Device
510(K) Number	K110852
Device Name	Insufflator, Hysteroscopic
Applicant	GYRUS ACMI, INC. 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	GRAHAM BAILLIE Other 510(k) Applications for this Contact
Regulation Number	884.1700   More FDA Info for this Regulation Number
Classification Product Code	HIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2011
Decision Date	07/19/2011
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