The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Surgical Mesh.
| Device ID | K040621 |
| 510k Number | K040621 |
| Device Name: | ACELL UBM SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase, MD 20815 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-09 |
| Decision Date | 2004-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001769 | K040621 | 000 |
| 00386190001752 | K040621 | 000 |
| 00386190001745 | K040621 | 000 |
| 00386190001738 | K040621 | 000 |