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 | K163647 |
| 510k Number | K163647 |
| Device Name: | Revolve Envi 600 Advanced Adipose System |
| Classification | System, Suction, Lipoplasty |
| Applicant | LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
| Contact | Anuja Yardi |
| Correspondent | Anuja Yardi 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 | 2016-12-23 |
| Decision Date | 2017-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M328RV0001E6000 | K163647 | 000 |