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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K113400
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
Correspondent Contact RACHEL KENNEDY
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GAT  
Date Received11/17/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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