Nexo-Gide Bilayer Collagen Membrane

Mesh, Surgical

Geistlich Pharma AG

The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Nexo-gide Bilayer Collagen Membrane.

Pre-market Notification Details

Device IDK203496
510k NumberK203496
Device Name:Nexo-Gide Bilayer Collagen Membrane
ClassificationMesh, Surgical
Applicant Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen,  CH 6110
ContactMarco Steiner
CorrespondentJoshua Crist
Biologics Consulting 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-07-14

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