FDA 510(k) Application Details - K232579

Device Classification Name	More FDA Info for this Device
510(K) Number	K232579
Device Name	Twoplus Applicator
Applicant	Hannah Life Technologies Pte Ltd. Morningstar Centre, 12 New Industrial Road, #04-05A Singapore 536202 SG Other 510(k) Applications for this Company
Contact	Prusothman M Sina Raja Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2023
Decision Date	12/21/2023
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