FDA 510(k) Application Details - K221737

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K221737
Device Name	Syringe, Piston
Applicant	Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Jennifer Antonacci Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2022
Decision Date	08/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review