FDA 510(k) Application Details - K192452

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K192452
Device Name	Mesh, Surgical
Applicant	B. Bruan Surgical, SA Carretera Terrassa 121 Rubi 08191 ES Other 510(k) Applications for this Company
Contact	Pau Turon Dols Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2019
Decision Date	09/03/2020
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