The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Fixate Tissue Band.
Device ID | K111462 |
510k Number | K111462 |
Device Name: | FIXATE TISSUE BAND |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
Contact | Rachel Kennedy |
Correspondent | Rachel Kennedy ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-26 |
Decision Date | 2011-09-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIXATE TISSUE BAND 85332335 4247597 Live/Registered |
BOSTON SCIENTIFIC NEUROMODULATION CORPOR 2011-05-27 |