Device Classification Name |
mesh, surgical
|
510(k) Number |
K192616 |
Device Name |
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) |
Applicant |
Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 |
Roswell,
GA
30076
|
|
Applicant Contact |
Wendy Perreault |
Correspondent |
Aziyo Biologics, Inc. |
1100 Old Ellis Road, Suite 1200 |
Roswell,
GA
30076
|
|
Correspondent Contact |
Wendy Perreault |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/23/2019 |
Decision Date | 10/21/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|