FDA 510(k) Application Details - K233689

Device Classification Name	Dilator, Vaginal   More FDA Info for this Device
510(K) Number	K233689
Device Name	Dilator, Vaginal
Applicant	Lujena, Inc. 11447 Rolling Hills Dr. El Cajon, CA 92020 US Other 510(k) Applications for this Company
Contact	Troy Gemmer Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	HDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2023
Decision Date	05/02/2024
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