FDA 510(k) Application Details - K251648

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K251648
Device Name	Syringe, Piston
Applicant	Prosidyan, Inc. 41 Spring Street #107 New Providence, NJ 07974 US Other 510(k) Applications for this Company
Contact	Tamala Wampler 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	05/29/2025
Decision Date	06/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review