The following data is part of a premarket notification filed by Aziyo Biologics, Inc. with the FDA for Cangaroo Envelope (small), Cangaroo Envelope (medium), Cangaroo Envelope (large), Cangaroo Envelope (extra Large), Cangaroo Envelope (extra Extra Large) (subq).
| Device ID | K192616 |
| 510k Number | K192616 |
| Device Name: | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large), CanGaroo Envelope (extra Extra Large) (SubQ) |
| Classification | Mesh, Surgical |
| Applicant | Aziyo Biologics, Inc. 1100 Old Ellis Road, Suite 1200 Roswell, GA 30076 |
| Contact | Wendy Perreault |
| Correspondent | Wendy Perreault Aziyo Biologics, Inc. 1100 Old Ellis Road, Suite 1200 Roswell, GA 30076 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2019-10-21 |
| Summary: | summary |