The following data is part of a premarket notification filed by Allergan with the FDA for Seri Surgical Scaffold.
| Device ID | K123128 |
| 510k Number | K123128 |
| Device Name: | SERI SURGICAL SCAFFOLD |
| Classification | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Applicant | ALLERGAN 200 BOSTON AVENUE SUITE 3700 Medford, MA 02155 -0000 |
| Contact | Connie Garrison |
| Correspondent | Connie Garrison ALLERGAN 200 BOSTON AVENUE SUITE 3700 Medford, MA 02155 -0000 |
| Product Code | OXF |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2013-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6119468001 | K123128 | 000 |
| B6119467909 | K123128 | 000 |
| B6119467808 | K123128 | 000 |
| B6119467707 | K123128 | 000 |