FDA 510(k) Application Details - K210997

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K210997
Device Name	Syringe, Piston
Applicant	MD3 LLC 3650 Coral Ridge Drive Suite 107 Coral Springs, FL 33065 US Other 510(k) Applications for this Company
Contact	Mary Ann Greenawalt 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	04/02/2021
Decision Date	09/07/2021
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