Device Classification Name |
barrier, animal source, intraoral
|
510(k) Number |
K171643 |
Device Name |
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed |
Applicant |
Geistlich Pharma AG |
Bahnhofstrasse 40 |
Wolhusen,
CH
ch- 6110
|
|
Applicant Contact |
Marco Steiner |
Correspondent |
Hogan Lovells US LLP. |
1835 Market Street, 29th Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 06/02/2017 |
Decision Date | 10/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|