The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Lyophilized Wound Dressing.
| Device ID | K021637 |
| 510k Number | K021637 |
| Device Name: | ACELL UBM LYOPHILIZED WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACELL, INC 815 CONNECTICUT AVE NW SUITE 800 Washington, DC 20006 |
| Contact | Patsy J Triser |
| Correspondent | Patsy J Triser ACELL, INC 815 CONNECTICUT AVE NW SUITE 800 Washington, DC 20006 |
| 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 | 2002-05-17 |
| Decision Date | 2002-12-19 |
| Summary: | summary |