FDA 510(k) Application Details - K222969

Device Classification Name	Cap, Cervical   More FDA Info for this Device
510(K) Number	K222969
Device Name	Cap, Cervical
Applicant	Rosesta Medical BV Mr. Treublaan 7 I Amsterdam 1079DP NL Other 510(k) Applications for this Company
Contact	Stal Robert Other 510(k) Applications for this Contact
Regulation Number	884.5250   More FDA Info for this Regulation Number
Classification Product Code	HDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2022
Decision Date	06/23/2023
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