The following data is part of a premarket notification filed by Acell, Inc with the FDA for Matristem Wound Matrix.
| Device ID | K112409 |
| 510k Number | K112409 |
| Device Name: | MATRISTEM WOUND MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACELL, INC 6640 ELI WHITNEY DRIVE SUITE 200 Columbia, MD 21046 |
| Contact | Deborah A Baker-janis |
| Correspondent | Deborah A Baker-janis ACELL, INC 6640 ELI WHITNEY DRIVE SUITE 200 Columbia, MD 21046 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190000786 | K112409 | 000 |
| 00386190000779 | K112409 | 000 |
| 00386190000762 | K112409 | 000 |