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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K053214
Device Name THERAKNIT GARMENT ELECTRODE
Applicant
Neurotron Medical
800 Silvia St.
Ewing,  NJ  08628
Applicant Contact JACK GULDALIAN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.1320
Classification Product Code
GXY  
Date Received11/17/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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