| Device Classification Name |
lipoaspirate washing system for aesthetic body contouring
|
| 510(k) Number |
BK220691 |
| Tradename |
LIPCOLLECTOR II (K101713)
|
| Device Name |
Lipoaspirate washing system for aesthetic body contouring |
| Original Applicant |
| HUMAN MED AG |
| wilhelm-hennemann-strasse 9 |
|
Schwerin,
D-19061,
|
|
| Regulation Number | 878.5040
|
| Classification Product Code |
|
| Date Received | 03/29/2022 |
| Decision Date | 06/29/2010 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
General & Plastic Surgery
|
| Review Advisory Committee |
General & Plastic Surgery
|
| Type |
510(k) Traditional
|
| Total Product Life Cycle (TPLC) |
TPLC Device Report
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
| In Vitro Product |
No
|