FIXATE TISSUE BAND


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K111462
Device Name FIXATE TISSUE BAND
Applicant
ANULEX TECHNOLOGIES, INC
5600 rowland road, ste 280
minnetonka, 
MN 
55343

Applicant Contact rachel kennedy
Correspondent
ANULEX TECHNOLOGIES, INC
5600 rowland road, ste 280
minnetonka, 
MN 
55343

Correspodent Contact rachel kennedy
Regulation Number 882.5880
Classification Product Code
GZB  
Subsequent Product Code
GAT  
Date Received 05/26/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No