FDA 510(k) Application Details - K250555

Device Classification Name	More FDA Info for this Device
510(K) Number	K250555
Device Name	MallyaD injection pen adapter (MallyaD)
Applicant	BioCorp Production ZI de Lavaur La Bechade 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	02/25/2025
Decision Date	03/27/2025
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