FDA 510(k) Application Details - K193479

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K193479
Device Name	Cerclage, Fixation
Applicant	A&E Medical Corporation 5206 Asbury Road, PO Box 758 Farmingdale, NJ 07727 US Other 510(k) Applications for this Company
Contact	Peter Browne Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2019
Decision Date	03/23/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review