The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Surgical Mesh Ml And Mlplus.
| Device ID | K041140 |
| 510k Number | K041140 |
| Device Name: | ACELL UBM SURGICAL MESH ML AND MLPLUS |
| 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 | 2004-04-30 |
| Decision Date | 2004-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001813 | K041140 | 000 |
| 00386190000892 | K041140 | 000 |
| 00386190000526 | K041140 | 000 |
| 00386190000519 | K041140 | 000 |
| 00386190000502 | K041140 | 000 |
| 00386190000496 | K041140 | 000 |
| 00386190000489 | K041140 | 000 |
| 00386190000472 | K041140 | 000 |
| 00386190000465 | K041140 | 000 |
| 00386190000908 | K041140 | 000 |
| 00386190000915 | K041140 | 000 |
| 00386190000922 | K041140 | 000 |
| 00386190001790 | K041140 | 000 |
| 00386190001585 | K041140 | 000 |
| 00386190001578 | K041140 | 000 |
| 00386190001561 | K041140 | 000 |
| 00386190001554 | K041140 | 000 |
| 00386190001547 | K041140 | 000 |
| 00386190001530 | K041140 | 000 |
| 00386190001523 | K041140 | 000 |
| 00386190000458 | K041140 | 000 |