The following data is part of a premarket notification filed by Helsinn Healthcare Sa with the FDA for Xonrid Gel.
| Device ID | K152533 |
| 510k Number | K152533 |
| Device Name: | Xonrid Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | Helsinn Healthcare SA Via Pain Scairolo 9 Lugano, CH 6912 |
| Contact | Valentina Tombolini Bossi |
| Correspondent | Barbara A Binzak Blumenfeld Buchanan, Ingersoll, & Rooney PC 1700 K Street NW Suite 300 Washington, DC 20006 |
| 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 | 2015-09-03 |
| Decision Date | 2016-10-28 |
| Summary: | summary |