The following data is part of a premarket notification filed by Laboratoires Urgo with the FDA for Urgotul Ag.
| Device ID | K061220 |
| 510k Number | K061220 |
| Device Name: | URGOTUL AG |
| Classification | Dressing, Wound, Drug |
| Applicant | LABORATOIRES URGO 42, RUE DE LONGVIC Chenove, FR 21300 |
| Contact | Sophie Fortin |
| Correspondent | Sophie Fortin LABORATOIRES URGO 42, RUE DE LONGVIC Chenove, FR 21300 |
| 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 | 2006-05-01 |
| Decision Date | 2006-07-27 |
| Summary: | summary |