FDA 510(k) Application Details - K201338

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K201338
Device Name	Syringe, Piston
Applicant	LifeNet Health 1864 Concert Drive Virginia Beach, VA 23453 US Other 510(k) Applications for this Company
Contact	Brittany Beasley 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	05/20/2020
Decision Date	07/13/2020
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