FDA 510(k) Application Details - K243164

Device Classification Name	More FDA Info for this Device
510(K) Number	K243164
Device Name	INDIBA COMPACT devices
Applicant	INDIBA S. A. U. Carrer del MoianΦs, 13 Sant Quirze del VallΦs 08192 ES Other 510(k) Applications for this Company
Contact	Nieves Arias Badia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	11/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review