FDA 510(k) Application Details - K192644

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K192644
Device Name	Media, Reproductive
Applicant	Hamilton Thorne Incorporated 100 Cummings Center, Suite 465E Beverly, MA 01915 US Other 510(k) Applications for this Company
Contact	Donald Fournier Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2019
Decision Date	04/23/2020
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