The following data is part of a premarket notification filed by Organogenesis, Inc. with the FDA for Fortaderm Wound Dressing.
| Device ID | K011026 |
| 510k Number | K011026 |
| Device Name: | FORTADERM WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Contact | Patrick R Bilbo |
| Correspondent | Patrick R Bilbo ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| 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 | 2001-04-04 |
| Decision Date | 2001-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00618474000152 | K011026 | 000 |
| 00618474000022 | K011026 | 000 |
| 00618474000060 | K011026 | 000 |
| 00618474000053 | K011026 | 000 |