The following data is part of a premarket notification filed by Human Med Ag with the FDA for Lipcollector Ii.
| Device ID | K101713 |
| 510k Number | K101713 |
| Device Name: | LIPCOLLECTOR II |
| Classification | System, Suction, Lipoplasty |
| Applicant | HUMAN MED AG WILHELM-HENNEMANN-STR.9 Schwerin, DE 19061 |
| Contact | Inge Matthiesen |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-06-29 |
| Summary: | summary |