FDA 510(k) Application Details - K212911

Device Classification Name	Clamp, Circumcision   More FDA Info for this Device
510(K) Number	K212911
Device Name	Clamp, Circumcision
Applicant	Medline Industries, Inc Three Lakes Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Jennifer Mason Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2021
Decision Date	11/18/2022
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