FDA 510(k) Application Details - K203626

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K203626
Device Name	Labware, Assisted Reproduction
Applicant	Allwin Medical Devices, Inc 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 US Other 510(k) Applications for this Company
Contact	Digish Mehta Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2020
Decision Date	06/04/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review