The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Cytal Wound Matrix 3-layer.
| Device ID | K192725 |
| 510k Number | K192725 |
| Device Name: | Cytal Wound Matrix 3-Layer |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner 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 | 2019-09-27 |
| Decision Date | 2019-10-25 |
| Summary: | summary |