FDA 510(k) Application Details - K133799

Device Classification Name	Insufflator, Hysteroscopic   More FDA Info for this Device
510(K) Number	K133799
Device Name	Insufflator, Hysteroscopic
Applicant	THERMEDX LLC 31200 SOLON RD., UNIT #1 SOLON, OH 44139 US Other 510(k) Applications for this Company
Contact	JEFF WILLIAMS 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	12/13/2013
Decision Date	06/20/2014
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