FDA 510(k) Application Details - K212757

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K212757
Device Name	Intrauterine Tamponade Balloon
Applicant	Alydia Health 3495 Edison Way Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Colby Holtshouse Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	OQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2021
Decision Date	09/30/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review