The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Dominant 50 Lipo, Model 600-5706.
| Device ID | K063336 |
| 510k Number | K063336 |
| Device Name: | MEDELA DOMINANT 50 LIPO, MODEL 600-5706 |
| Classification | System, Suction, Lipoplasty |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Werner Frei |
| Correspondent | Werner Frei MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-02-26 |
| Summary: | summary |