The following data is part of a premarket notification filed by Biotd, S.a. with the FDA for Spb Skin Emulsion.
| Device ID | K141637 |
| 510k Number | K141637 |
| Device Name: | SPB SKIN EMULSION |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOTD, S.A. 816 CONGRESS AVENUE - STE 1400 Austin, TX 78701 |
| Contact | Richard Gillis, Ph.d. |
| Correspondent | Richard Gillis, Ph.d. 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 | 2014-06-19 |
| Decision Date | 2015-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00315455956612 | K141637 | 000 |
| 00328595282022 | K141637 | 000 |