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 |