FDA 510(k) Application Details - K223098

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K223098
Device Name	Intrauterine Tamponade Balloon
Applicant	Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Ian Herman 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	09/30/2022
Decision Date	10/28/2022
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