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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 K053503
Device Name VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
Applicant
Vax-D Medical Technologies USA, L.C.
310 Mears Blvd.
Oldsmar,  FL  34677
Applicant Contact LAWRENCE DYER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.5900
Classification Product Code
ITH  
Date Received12/16/2005
Decision Date 12/28/2005
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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