The following data is part of a premarket notification filed by Laboratoires Urgo with the FDA for Urgocell Ag, Antimicrobial Wound Dressing With Silver.
| Device ID | K100429 |
| 510k Number | K100429 |
| Device Name: | URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-02-16 |
| Decision Date | 2010-06-11 |
| Summary: | summary |