The following data is part of a premarket notification filed by Eclipsemed Global, Inc with the FDA for Fusion System.
Device ID | K093465 |
510k Number | K093465 |
Device Name: | FUSION SYSTEM |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
Contact | Igor Gradov |
Correspondent | Igor Gradov ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-06 |
Decision Date | 2010-01-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FUSION SYSTEM 90478027 not registered Live/Pending |
Biomea Fusion, Inc. 2021-01-20 |
![]() FUSION SYSTEM 76114274 not registered Dead/Abandoned |
NEXICOR, LLC 2000-08-22 |