510(k) K203496

Nexo-Gide Bilayer Collagen Membrane by Geistlich Pharma AG — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2021
Date Received
November 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type