The following data is part of a premarket notification filed by Organogenesis, Inc. with the FDA for Fortaderm Antimicrobial Wound Dressing.
| Device ID | K051647 |
| 510k Number | K051647 |
| Device Name: | FORTADERM ANTIMICROBIAL WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Contact | Patrick Bilbo |
| Correspondent | Patrick Bilbo ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-06-21 |
| Decision Date | 2005-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00618474000121 | K051647 | 000 |
| 00618474000442 | K051647 | 000 |
| 00618474000459 | K051647 | 000 |
| 00618474000435 | K051647 | 000 |
| 00618474000039 | K051647 | 000 |
| 00618474000084 | K051647 | 000 |
| 00618474000091 | K051647 | 000 |
| 00618474000107 | K051647 | 000 |
| 00618474000114 | K051647 | 000 |
| 00618474000466 | K051647 | 000 |