The following data is part of a premarket notification filed by Biotd, S.a. with the FDA for Ross Ru Wound Dressing Gel.
| Device ID | K162017 |
| 510k Number | K162017 |
| Device Name: | Ross Ru Wound Dressing Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOTD, S.A. EDIFICIO 26 CONDOMINIO INDUSTRIAL SAN JOSE DE ULLOA Heredia, CR |
| Contact | Lawrence Pratt |
| Correspondent | Richard Gillis EMERGO GROUP 816 CONGRESS AVE SUITE 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 | 2016-07-21 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00315455956834 | K162017 | 000 |