FDA 510(k) Application Details - K230849

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K230849
Device Name	Intrauterine Tamponade Balloon
Applicant	SINAPI Biomedical (Pty) Ltd. 1 Lelie Road Stellenbosch 7600 ZA Other 510(k) Applications for this Company
Contact	Chris de Villiers 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	03/28/2023
Decision Date	11/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review