The following data is part of a premarket notification filed by Acell, Inc with the FDA for Matristem Surgery Matrix Rs, Psm, Psmx, Matristem Pelvic Floor Matrix.
| Device ID | K141084 |
| 510k Number | K141084 |
| Device Name: | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix |
| Classification | Mesh, Surgical |
| Applicant | ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia, MD 21046 |
| Contact | Salman Elmi |
| Correspondent | Salman Elmi ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia, MD 21046 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-28 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001295 | K141084 | 000 |
| 00386190000397 | K141084 | 000 |
| 00386190000380 | K141084 | 000 |
| 00386190000373 | K141084 | 000 |
| 00386190000366 | K141084 | 000 |
| 00386190000359 | K141084 | 000 |
| 00386190000342 | K141084 | 000 |
| 00386190000335 | K141084 | 000 |
| 00386190000304 | K141084 | 000 |
| 00386190000298 | K141084 | 000 |
| 00386190000281 | K141084 | 000 |
| 00386190000274 | K141084 | 000 |
| 00386190000267 | K141084 | 000 |
| 00386190000403 | K141084 | 000 |
| 00386190000410 | K141084 | 000 |
| 00386190001288 | K141084 | 000 |
| 00386190001271 | K141084 | 000 |
| 00386190001264 | K141084 | 000 |
| 00386190001257 | K141084 | 000 |
| 00386190000861 | K141084 | 000 |
| 00386190000854 | K141084 | 000 |
| 00386190000847 | K141084 | 000 |
| 00386190000830 | K141084 | 000 |
| 00386190000533 | K141084 | 000 |
| 00386190000441 | K141084 | 000 |
| 00386190000434 | K141084 | 000 |
| 00386190000427 | K141084 | 000 |
| 00386190000250 | K141084 | 000 |