The following data is part of a premarket notification filed by Stemics S.a.s with the FDA for Kta Adipose Treatment Kit.
| Device ID | K190386 |
| 510k Number | K190386 |
| Device Name: | KTA Adipose Treatment Kit |
| Classification | System, Suction, Lipoplasty |
| Applicant | Stemics S.A.S 2 Rue Professeur Paul Milleret Besancon, FR 25000 |
| Contact | Stephane Giraud |
| Correspondent | Catherine Gloster Gloster Biomedical International, LLC 577 North Hope Avenue Santa Barbara, CA 93110 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-10-10 |
| Summary: | summary |