The following data is part of a premarket notification filed by Human Med Ag with the FDA for Body-jet.
Device ID | K082025 |
510k Number | K082025 |
Device Name: | BODY-JET |
Classification | System, Suction, Lipoplasty |
Applicant | HUMAN MED AG WILHELM-HENNEMANN-STR.9 Schwerin, DE 19061 |
Contact | Inge Matthiesen |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-07-17 |
Decision Date | 2008-08-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BODY-JET 79088933 3980301 Live/Registered |
Human Med AG 2010-09-16 |
BODY-JET 77823470 3792602 Live/Registered |
Human Med AG 2009-09-10 |