The following data is part of a premarket notification filed by Laboratoires Urgo with the FDA for Urgoclean Absorbent Wound Dressing.
| Device ID | K123219 |
| 510k Number | K123219 |
| Device Name: | URGOCLEAN ABSORBENT WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | LABORATOIRES URGO EXCELLENCE 2000 2 AVENUE DE STRASBOURG Chevigny Saint Sauveur, FR 21801 |
| Contact | Sophie Fortin |
| Correspondent | Sophie Fortin LABORATOIRES URGO EXCELLENCE 2000 2 AVENUE DE STRASBOURG Chevigny Saint Sauveur, FR 21801 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-03-18 |
| Summary: | summary |