FDA 510(k) Application Details - K192674

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K192674
Device Name	Syringe, Piston
Applicant	Bone Solutions, Inc. 5712 Colleyville Blvd, STE 210 Colleyville, TX 76034 US Other 510(k) Applications for this Company
Contact	Drew Diaz 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	09/26/2019
Decision Date	02/18/2020
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