The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Cytal Wound Particulate.
| Device ID | K180776 |
| 510k Number | K180776 |
| Device Name: | Cytal Wound Particulate |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Contact | Andrea Artman |
| Correspondent | John Smith Hogan Lovells 555 Thirteenth St., NW Washington, DC 20004 |
| 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 | 2018-03-23 |
| Decision Date | 2018-05-11 |
| Summary: | summary |