The following data is part of a premarket notification filed by Alacer Biomedical Inc with the FDA for Alacer Surgical Scaffold.
| Device ID | K103445 |
| 510k Number | K103445 |
| Device Name: | ALACER SURGICAL SCAFFOLD |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ALACER BIOMEDICAL INC 200 BOSTON AVENUE SUITE 3700 Medford, MA 02155 |
| Contact | Connie Garrison |
| Correspondent | Connie Garrison ALACER BIOMEDICAL INC 200 BOSTON AVENUE SUITE 3700 Medford, MA 02155 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-02-22 |