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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 K060735
Device Name DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
Applicant
AXIOM WORLDWIDE, INC.
9423 CORPORATE LAKE DRIVE
TAMPA,  FL  33634
Applicant Contact JIM GIBSON
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number890.5900
Classification Product Code
ITH  
Date Received03/20/2006
Decision Date 05/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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