The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Matristem Wound Sheet.
| Device ID | K092926 |
| 510k Number | K092926 |
| Device Name: | ACELL MATRISTEM WOUND SHEET |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACELL, INC 8671 ROBERT FULTON DRIVE SUITE B Columbia, MD 21046 |
| Contact | Rodney W Bosley |
| Correspondent | Rodney W Bosley ACELL, INC 8671 ROBERT FULTON DRIVE SUITE B 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 | 2009-09-23 |
| Decision Date | 2009-10-28 |
| Summary: | summary |