FDA 510(k) Application Details - K251500

Device Classification Name	More FDA Info for this Device
510(K) Number	K251500
Device Name	MallyaG Injection Pen Adapter (MallyaG)
Applicant	Biocorp Production Zi Lavaur -La BΘchade Issoire 63500 FR Other 510(k) Applications for this Company
Contact	Alexia Garin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2025
Decision Date	06/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review