FDA 510(k) Application Details - K250262

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K250262
Device Name	Syringe, Piston
Applicant	GO-Pen ApS Diplomvej 381 C/O DTU Science Park Kongens Lyngby 2800 DK Other 510(k) Applications for this Company
Contact	Ole Nielsen 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	01/29/2025
Decision Date	04/24/2025
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