The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Revolve Envi 600 Advanced Adipose System.
Device ID | K193539 |
510k Number | K193539 |
Device Name: | REVOLVE ENVI 600 Advanced Adipose System |
Classification | System, Suction, Lipoplasty |
Applicant | LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
Contact | Bozhana Hegarty |
Correspondent | Bozhana Hegarty LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-20 |
Decision Date | 2020-05-28 |