The following data is part of a premarket notification filed by Osyris Medical with the FDA for Lipocontrol.
Device ID | K090754 |
510k Number | K090754 |
Device Name: | LIPOCONTROL |
Classification | Laser Assisted Lipolysis |
Applicant | OSYRIS MEDICAL 60 AVENUE HALLEY F59650 VILLENEUVE D'ASQ France, FR F59650 |
Contact | Blandine Bouvet |
Correspondent | Blandine Bouvet OSYRIS MEDICAL 60 AVENUE HALLEY F59650 VILLENEUVE D'ASQ France, FR F59650 |
Product Code | ORK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-20 |
Decision Date | 2011-01-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIPOCONTROL 77620890 3691621 Dead/Cancelled |
LSO MEDICAL 2008-11-24 |