FDA 510(k) Application Details - K171440

Device Classification Name	System, Abortion, Vacuum   More FDA Info for this Device
510(K) Number	K171440
Device Name	System, Abortion, Vacuum
Applicant	Gyrus ACMI 136 Turnpike Rd Southborough, MA 01772 US Other 510(k) Applications for this Company
Contact	Christina Flores Other 510(k) Applications for this Contact
Regulation Number	884.5070   More FDA Info for this Regulation Number
Classification Product Code	HHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2017
Decision Date	09/29/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review