The following data is part of a premarket notification filed by Sofregen Medical, Inc. with the FDA for Seri Contour.
| Device ID | K172545 |
| 510k Number | K172545 |
| Device Name: | SERI Contour |
| Classification | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Applicant | Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155 |
| Contact | Anh Hoang |
| Correspondent | Anh Hoang Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155 |
| Product Code | OXF |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-23 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B611955121 | K172545 | 000 |