FDA 510(k) Application Details - K200248

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K200248
Device Name	Catheter, Assisted Reproduction
Applicant	Allwin Medical Devices, Inc. 3305 East Mira Loma Avenue, STE 176 Anaheim, CA 92806 US Other 510(k) Applications for this Company
Contact	Digish Mehta Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2020
Decision Date	07/01/2020
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