The following data is part of a premarket notification filed by Genesis Biosystems, Inc. with the FDA for Lipivage.
Device ID | K172714 |
510k Number | K172714 |
Device Name: | LipiVage |
Classification | System, Suction, Lipoplasty |
Applicant | Genesis Biosystems, Inc. 1500 Eagle Court Lewisville, TX 75057 |
Contact | Jim Lafferty |
Correspondent | Stuart R. Goldman Emergo Global Consulting , LLC 2500 Bee Cave Road, Bldg 1, Suite 300 Austin, TX 78746 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-08 |
Decision Date | 2017-12-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIPIVAGE 85839976 not registered Dead/Abandoned |
Genesis Biosystems, Inc. 2013-02-04 |
LIPIVAGE 78544352 3095184 Live/Registered |
Genesis Biosystems, Inc. 2005-01-08 |