FDA 510(k) Application Details - K233368

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K233368
Device Name	Syringe, Piston
Applicant	Bioventus LLC 4721 Emperor Blvd. Suite 100 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Shanna Hu 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	10/02/2023
Decision Date	06/25/2024
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