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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K031227
Device Name LORDEX POWER TRACTION EQUIPMENT
Applicant
Ever Prosperous Instrument, Inc.
15915 Katy Fwy.
Suite 645
Houston,  TX  77094
Applicant Contact JOHN BOREN
Correspondent
Ever Prosperous Instrument, Inc.
15915 Katy Fwy.
Suite 645
Houston,  TX  77094
Correspondent Contact JOHN BOREN
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/18/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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