FDA 510(k) Application Details - K202241

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	K202241
Device Name	System, Assisted Reproduction Laser
Applicant	Hamilton Thorne, Inc. 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	884.6200   More FDA Info for this Regulation Number
Classification Product Code	MRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2020
Decision Date	07/02/2021
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