Device Classification Name |
mesh, surgical
|
510(k) Number |
K203496 |
Device Name |
Nexo-Gide Bilayer Collagen Membrane |
Applicant |
Geistlich Pharma AG |
Bahnhofstrasse 40 |
Wolhusen,
CH
6110
|
|
Applicant Contact |
Marco Steiner |
Correspondent |
Biologics Consulting |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Joshua Crist |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/27/2020 |
Decision Date | 07/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|