The following data is part of a premarket notification filed by Biotd, S.a. with the FDA for Ross Ru Skin Discontinuities.
| Device ID | K131176 |
| 510k Number | K131176 |
| Device Name: | ROSS RU SKIN DISCONTINUITIES |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOTD, S.A. 816 CONGRESS AVENUE - STE 1400 Austin, TX 78701 |
| Contact | Richard Gillis |
| Correspondent | Richard Gillis BIOTD, S.A. 816 CONGRESS AVENUE - STE 1400 Austin, TX 78701 |
| 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 | 2013-04-25 |
| Decision Date | 2014-05-12 |
| Summary: | summary |