FDA 510(k) Application Details - K220891

Device Classification Name	More FDA Info for this Device
510(K) Number	K220891
Device Name	Kahook Dual Blade Glide (KDB Glide)
Applicant	New World Medical, Inc. 10763 Edison Court Rancho Cucamonga, CA 91730 US Other 510(k) Applications for this Company
Contact	Victor Arellano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2022
Decision Date	05/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review