FDA 510(k) Application Details - K190996

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K190996
Device Name	Syringe, Piston
Applicant	Bonus Therapeutics Ltd. Matam Advanced Technology Park, Building 8B Haifa 3190501 IL Other 510(k) Applications for this Company
Contact	Nir Shtayer 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	04/16/2019
Decision Date	07/28/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review