FDA 510(k) Application Details - K203496

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K203496
Device Name	Mesh, Surgical
Applicant	Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen 6110 CH Other 510(k) Applications for this Company
Contact	Marco Steiner 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	11/27/2020
Decision Date	07/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review