FDA 510(k) Application Details - K231095

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K231095
Device Name	Syringe, Piston
Applicant	International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 US Other 510(k) Applications for this Company
Contact	David Meily 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	04/18/2023
Decision Date	09/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review