FDA 510(k) Application Details - K230966

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K230966
Device Name	Clip, Implantable
Applicant	A2 Medical Systems, LLC 6387 Technology Ave. Kalamazoo, MI 49009 US Other 510(k) Applications for this Company
Contact	Robert Hall Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2023
Decision Date	09/19/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review