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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K020427
Device Name AB BELT
Applicant
THE DEZAC GROUP
719 A ST. NE
WASHINGTON,  DC 
Applicant Contact WENDY PARSLEY
Correspondent
THE DEZAC GROUP
719 A ST. NE
WASHINGTON,  DC 
Correspondent Contact WENDY PARSLEY
Regulation Number890.5850
Classification Product Code
NGX  
Date Received02/08/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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