The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Powder Wound Dressing.
| Device ID | K060888 |
| 510k Number | K060888 |
| Device Name: | ACELL POWDER WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACELL, INC 5600 WISCONSIN AVE. SUITE 509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler ACELL, INC 5600 WISCONSIN AVE. SUITE 509 Chevy Chase, MD 20815 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-06-23 |
| Summary: | summary |