FDA 510(k) Application Details - K203820

Device Classification Name	Tenaculum, Uterine   More FDA Info for this Device
510(K) Number	K203820
Device Name	Tenaculum, Uterine
Applicant	Aspivix S.A. Chemin du Closel Renens 1020 CH Other 510(k) Applications for this Company
Contact	Benjamin Klein Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2020
Decision Date	08/17/2021
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