The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Fat Concentration System.
| Device ID | K100114 |
| 510k Number | K100114 |
| Device Name: | FAT CONCENTRATION SYSTEM |
| Classification | System, Suction, Lipoplasty |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-15 |
| Decision Date | 2010-09-29 |
| Summary: | summary |