Device Classification Name |
mesh, surgical
|
510(k) Number |
K192452 |
Device Name |
Lyograft |
Applicant |
B. Bruan Surgical, SA |
Carretera Terrassa 121 |
Rubi,
ES
08191
|
|
Applicant Contact |
Pau Turon Dols |
Correspondent |
Qreg Consulting, LLC |
2192 Martin Drive |
Gilbertsville,
PA
19525
|
|
Correspondent Contact |
Robin M Fatzinger |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/09/2019 |
Decision Date | 09/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|