FDA 510(k) Application Details - K180937

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K180937
Device Name	Syringe, Piston
Applicant	Surgentec, LLC 7601 N Federal Hwy #150A Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Boca Raton 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	04/10/2018
Decision Date	05/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review