FDA 510(k) Application Details - K180825

Device Classification Name	Insufflator, Hysteroscopic   More FDA Info for this Device
510(K) Number	K180825
Device Name	Insufflator, Hysteroscopic
Applicant	Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Christine Cameron 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	03/30/2018
Decision Date	08/03/2018
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