FDA 510(k) Application Details - K190590

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K190590
Device Name	Needle, 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	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2019
Decision Date	11/25/2019
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